Ceramco® Ic
13 Shades. Contains Ceramco iC Paste Opaques, Paste Opaque Modifiers, Opaque Crystals, Opaceous Dentins, Dentins, HC Modifiers, Enamels, Margins, Final Margins, Add-Ons, Tissue Tints,…
13 Shades. Contains Ceramco iC Paste Opaques, Paste Opaque Modifiers, Opaque Crystals, Opaceous Dentins, Dentins, HC Modifiers, Enamels, Margins, Final Margins, Add-Ons, Tissue Tints, Stains, and Overglaze
33manufacturers in China registered for this device type
472catalogue numbers in this listing
27510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BMF Tech (Zhuhai) Inc. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Jiangxi Rekonova Dental Materials Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 1 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2023-12-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Weight 2 to 50 g; total volume 2 to 3.5 ml |
| Distribution end date | 2022-06-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Dentin D3 | Weight 50 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin Shade Stain SS-101 | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin Shade Stain A2 | Total Volume 2 ml | Withdrawn | |
| Dentin CC-420 | Weight 15 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Enamel Shade Stain Extra Light | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain SS-206 | Total Volume 2 ml | Withdrawn | |
| Integrated Trial Kit | Withdrawn | ||
| Opaceous Dentin C4 | Weight 15 g | Withdrawn | |
| Dentin CC-204 | Weight 15 g | Withdrawn | |
| Natural Enamel Extra Light | Weight 50 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin B1 | Weight 50 g | Withdrawn | |
| Final Margin FM7 | Weight 15 g | Withdrawn | |
| Natural Enamel Dark Blue | Weight 15 g | Withdrawn | |
| Press-to-Metal Margins PM7 | Weight 15 g | Withdrawn | |
| Opaceous Dentin A2 | Weight 50 g | Withdrawn | |
| Opaceous Dentin A3.5 | Weight 50 g | Withdrawn | |
| Final Margin FM8 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain SS-421 | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin D4 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain SS-419 | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin Shade Stain SS-203 | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Value Series Ingots | Weight 5 g | 5 | Withdrawn |
| Dentin Shade Stain A3.5 | Total Volume 2 ml | Withdrawn | |
| Opal Enamel Clear | Weight 15 g | Withdrawn | |
| Dentin Shade Stain SS-312 | Total Volume 2 ml | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Enamel Shade Stain Medium | Total Volume 2 ml | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Stain Dark Orange | Weight 3 g | Withdrawn | |
| High Chroma Modifier White | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-206 | Weight 15 g | Withdrawn | |
| Dentin CC-524 | Weight 50 g | Withdrawn | |
| Final Margin FM6 | Weight 15 g | Withdrawn | |
| Dentin A2 | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin CC-310 | Weight 50 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain SS-524 | Total Volume 2 ml | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin/Enamel Value Series Ingots | Weight 2 g | 5 | Withdrawn |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain C2 | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-205 | Weight 15 g | Withdrawn | |
| Dentin CC-421 | Weight 50 g | Withdrawn | |
| Stain Corn Yellow | Weight 3 g | Withdrawn | |
| Dentin CC-316 | Weight 50 g | Withdrawn | |
| Dentin CC-204 | Weight 50 g | Withdrawn | |
| Margin M9 | Weight 15 g | Withdrawn | |
| Dentin C3 | Weight 50 g | Withdrawn | |
| Opaceous Dentin CC-525 | Weight 15 g | Withdrawn | |
| Natural Enamel Super Clear | Weight 15 g | Withdrawn | |
| Veneering System Paste Opaque Kit | Withdrawn | ||
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Neutral Ingots 2G Narrow CC-OC1 | Weight 2 g | 5 | Withdrawn |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain SS-313 | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain SS-315 | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain SS-208 | Total Volume 2 ml | Withdrawn | |
| High Chroma Modifier HC5 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain B1 | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-526 | Weight 15 g | Withdrawn | |
| Add-On Porcelain Light | Weight 15 g | Withdrawn | |
| Stain Amber | Weight 3 g | Withdrawn | |
| Dentin CC-206 | Weight 50 g | Withdrawn | |
| Opaceous Dentin C4 | Weight 50 g | Withdrawn | |
| Opal Enamel Light | Weight 15 g | Withdrawn | |
| Opaceous Dentin D2 | Weight 50 g | Withdrawn | |
| Press-to-Metal Margins PM6 | Weight 15 g | Withdrawn | |
| Opaque Corrector Dark | Weight 15 g | Withdrawn | |
| Opaceous Dentin B4 | Weight 50 g | Withdrawn | |
| Dentin CC-422 | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-418 | Weight 50 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Final Margin FM4 | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-311 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain SS-205 | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-419 | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-206 | Weight 50 g | Withdrawn | |
| Opaceous Dentin CC-417 | Weight 50 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin D4 | Weight 15 g | Withdrawn | |
| Dentin CC-423 | Weight 50 g | Withdrawn | |
| Margin M5 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain A1 | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-420 | Weight 50 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin Shade Stain C4 | Total Volume 2 ml | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Stain Dove Blue | Weight 3 g | Withdrawn | |
| Stain Yellow | Weight 3 g | Withdrawn | |
| Dentin/Enamel Value Series Ingots | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin CC-101 | Weight 15 g | Withdrawn | |
| Press-to-Metal Margins SPM Green-Brown | Weight 15 g | Withdrawn | |
| Dentin CC-208 | Weight 50 g | Withdrawn | |
| Add-On Tissue Tint Porcelain | Weight 15 g | Withdrawn | |
| Dentin CC-206 | Weight 15 g | Withdrawn | |
| High Chroma Modifier Pink | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-423 | Weight 50 g | Withdrawn | |
| High Chroma Modifier HC6 | Weight 15 g | Withdrawn | |
| Natural Enamel Dark Orange | Weight 15 g | Withdrawn | |
| Natural Enamel Pink | Weight 15 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin CC-310 | Weight 50 g | Withdrawn | |
| Dentin CC-001 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain SS-526 | Total Volume 2 ml | Withdrawn | |
| Dentin CC-315 | Weight 15 g | Withdrawn | |
| Natural Enamel Light | Weight 15 g | Withdrawn | |
| Dentin D4 | Weight 50 g | Withdrawn | |
| Neutral Ingots 2G Narrow CC-05 | Weight 2 g | 5 | Withdrawn |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin CC-003 | Weight 50 g | Withdrawn | |
| Dentin CC-101 | Weight 50 g | Withdrawn | |
| Dentin A3 | Weight 15 g | Withdrawn | |
| Dentin CC-311 | Weight 50 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin CC-419 | Weight 15 g | Withdrawn | |
| Dentin A3 | Weight 50 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin B4 | Weight 50 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin B1 | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-203 | Weight 50 g | Withdrawn | |
| Dentin CC-207 | Weight 50 g | Withdrawn | |
| Opaceous Dentin A2 | Weight 15 g | Withdrawn | |
| Paste Opaque Modifier Pink | Total Volume 3.5 ml | Withdrawn | |
| Opaceous Dentin C3 | Weight 50 g | Withdrawn | |
| Dentin CC-209 | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-313 | Weight 15 g | Withdrawn | |
| Dentin/Enamel Value Series Ingots | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin A4 | Weight 50 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-209 | Weight 15 g | Withdrawn | |
| Dentin CC-209 | Weight 50 g | Withdrawn | |
| Opaceous Dentin D2 | Weight 15 g | Withdrawn | |
| Dentin B4 | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-000 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain SS-001 | Total Volume 2 ml | Withdrawn | |
| Paste Opaque Modifier Violet | Total Volume 3.5 ml | Withdrawn | |
| Opaceous Dentin CC-310 | Weight 15 g | Withdrawn | |
| Paste Opaque Modifier White | Total Volume 3.5 ml | Withdrawn | |
| Opaceous Dentin D3 | Weight 50 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin CC-524 | Weight 50 g | Withdrawn | |
| Opaceous Dentin B3 | Weight 15 g | Withdrawn | |
| Overglaze Paste | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-002 | Weight 50 g | Withdrawn | |
| Dentin CC-310 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain D3 | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Press-to-Metal Margins PM3 | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-205 | Weight 50 g | Withdrawn | |
| Dentin CC-420 | Weight 50 g | Withdrawn | |
| Press-to-Metal Margins PM1 | Weight 15 g | Withdrawn | |
| Veneering System Paste Opaque Kit | Withdrawn | ||
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| All-Ceramic Pressing Kit | Withdrawn | ||
| Dentin CC-003 | Weight 50 g | Withdrawn | |
| High Chroma Modifier Gray | Weight 15 g | Withdrawn | |
| Opaceous Dentin CC-419 | Weight 50 g | Withdrawn | |
| Dentin/Enamel Value Series Ingots | Weight 5 g | 5 | Withdrawn |
| Opaceous Dentin B1 | Weight 15 g | Withdrawn | |
| Margin M1 | Weight 15 g | Withdrawn | |
| Stain Violet | Weight 3 g | Withdrawn | |
| Final Margin FM2 | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Neutral Ingots 2G Narrow CC-04 | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin CC-525 | Weight 50 g | Withdrawn | |
| Dentin CC-314 | Weight 15 g | Withdrawn | |
| Dentin CC-003 | Weight 15 g | Withdrawn | |
| Press-to-Metal Margins PM5 | Weight 15 g | Withdrawn | |
| Dentin CC-208 | Weight 15 g | Withdrawn | |
| Paste Opaque Modifier Brown | Total Volume 3.5 ml | Withdrawn | |
| Opaceous Dentin CC-316 | Weight 50 g | Withdrawn | |
| Dentin C3 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain SS-310 | Total Volume 2 ml | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin CC-421 | Weight 15 g | Withdrawn | |
| Opaceous Dentin C1 | Weight 15 g | Withdrawn | |
| Dentin CC-203 | Weight 15 g | Withdrawn | |
| Dentin D3 | Weight 15 g | Withdrawn | |
| Dentin CC-524 | Weight 15 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| High Chroma Modifier HC2 | Weight 15 g | Withdrawn | |
| Natural Enamel Medium | Weight 15 g | Withdrawn | |
| Dentin CC-205 | Weight 50 g | Withdrawn | |
| Dentin CC-418 | Weight 15 g | Withdrawn | |
| Mamelon Red-Orange | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Paste Opaque Modifier Burnt-Orange | Total Volume 3.5 ml | Withdrawn | |
| High Chroma Modifier Blue | Weight 15 g | Withdrawn | |
| Dentin A3.5 | Weight 50 g | Withdrawn | |
| High Chroma Modifier HC3 | Weight 15 g | Withdrawn | |
| Dentin CC-526 | Weight 50 g | Withdrawn | |
| Opal Enamel Medium | Weight 15 g | Withdrawn | |
| Natural Enamel Medium | Weight 50 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin CC-002 | Weight 50 g | Withdrawn | |
| Opaceous Dentin C1 | Weight 50 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin B4 | Weight 15 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Enamel Shade Stain Light | Total Volume 2 ml | Withdrawn | |
| Dentin CC-313 | Weight 15 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Stain White | Weight 3 g | Withdrawn | |
| Stain Red | Weight 3 g | Withdrawn | |
| Opaceous Dentin CC-314 | Weight 15 g | Withdrawn | |
| Natural Enamel Clear | Weight 50 g | Withdrawn | |
| Natural Enamel Dark Gray | Weight 15 g | Withdrawn | |
| Final Margin FM1 | Weight 15 g | Withdrawn | |
| Dentin D2 | Weight 50 g | Withdrawn | |
| Dentin/Enamel Value Series Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Opaceous Dentin CC-524 | Weight 15 g | Withdrawn | |
| Margin SM Green-Brown | Weight 15 g | Withdrawn | |
| Dentin B3 | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| High Chroma Modifier Yellow | Weight 15 g | Withdrawn | |
| Dentin Shade Stain A3 | Total Volume 2 ml | Withdrawn | |
| Margin M4 | Weight 15 g | Withdrawn | |
| Dentin Shade Stain B4 | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin A3 | Weight 50 g | Withdrawn | |
| Natural Enamel Light Blue | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain D4 | Total Volume 2 ml | Withdrawn | |
| Dentin/Enamel Value Series Ingots | Weight 2 g | 5 | Withdrawn |
| Add-On Porcelain Medium | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Opaceous Dentin C3 | Weight 15 g | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Natural Enamel Dark Yellow | Weight 15 g | Withdrawn | |
| Dentin/Enamel Shaded Ingots | Weight 2 g | 5 | Withdrawn |
| Dentin Shade Stain SS-314 | Total Volume 2 ml | Withdrawn | |
| Dentin Shade Stain SS-204 | Total Volume 2 ml | Withdrawn | |
| Paste Opaque Modifier Gray | Total Volume 3.5 ml | Withdrawn | |
| Universal Paste Opaque | Total Volume 2 ml | Withdrawn | |
| Dentin CC-101 | Weight 15 g | Withdrawn | |
| Add-On Tissue Tint Porcelain | Weight 15 g | Withdrawn | |
| Stain Gray | Weight 3 g | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bloomden | Bloomden Bioceramics (Hunan) Co., Ltd. | 6,340 |
| Upcera Dental Zirconia Blank For Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 4,367 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 4,310 |
| Luxen 5G | Dentalmax Co., Ltd. | 3,903 |
| GC Initial™ | GC America Inc. | 2,724 |
| Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2,035 |
| Multi M Series | Dmax Co., Ltd. | 1,854 |
| Zirconia Dental Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 1,828 |
| Amber® Mill Q | Hass Corp. | 1,602 |
| Upcera Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 1,498 |
| BruxZir | Prismatik Dentalcraft, Inc. | 1,295 |
| ceraMotion® | Dentaurum GmbH & Co. KG | 1,062 |
Showing 12 of 10,017. All products under Powder, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152247 | 2016-01-29 |
| K123615 | 2013-02-22 |
| K112152 | 2011-11-09 |
| K091706 | 2009-08-28 |
| K070019 | 2007-01-26 |
| K051462 | 2005-06-24 |
| K043247 | 2004-12-22 |
| K041707 | 2004-07-30 |
| K041335 | 2004-06-16 |
| K040635 | 2004-03-30 |
| K040421 | 2004-03-18 |
| K040420 | 2004-03-18 |
| K033667 | 2004-01-23 |
| K033553 | 2003-12-02 |
| K022796 | 2002-09-06 |
| K971869 | 1997-09-11 |
| K961291 | 1996-05-28 |
| K954761 | 1995-11-02 |
| K943582 | 1994-08-29 |
| K940252 | 1994-03-01 |
| K921619 | 1992-07-02 |
| K915543 | 1992-03-19 |
| K900393 | 1990-04-16 |
| K853707 | 1985-11-19 |
| K830955 | 1983-05-09 |
| K830553 | 1983-04-06 |
| K810096 | 1981-03-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.