Ceramco® II
Universal G and B Shades High-Value Red-Yellow
33manufacturers in China registered for this device type
331catalogue 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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Weight 10 to 113.4 g; total volume 2 to 5 ml |
| Distribution end date | 2022-05-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| G Shades A-4 | Weight 113.4 g | Withdrawn |
| Opaceous Body A-3 | Weight 28.4 g | Withdrawn |
| G Shades B-1 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Yellow | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B Shades 69 | Weight 28.4 g | Withdrawn |
| G Shades D-4 | Weight 113.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Incisal Porcelain Extra Light | Weight 113.4 g | Withdrawn |
| Opal Incisal Porcelains Ivory | Weight 10 g | Withdrawn |
| G Shades B-4 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| G Shades B-2 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| High Value Paint-O-Pake G Shades B-4 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Dark | Weight 28.4 g | Withdrawn |
| Body Modifiers, Hue Modifiers | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B Shades 66 | Weight 28.4 g | Withdrawn |
| Extended Range B Shades 54 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| Paint-O-Pake B Shades 82 | Weight 28.4 g | Withdrawn |
| Opaceous Body A-3.5 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Orange | Weight 113.4 g | Withdrawn |
| G Shades B-0 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-4 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-3.5 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 69 | Weight 28.4 g | Withdrawn |
| Body Modifiers, Hue Modifiers | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Light | Weight 113.4 g | Withdrawn |
| Paint-O-Pake B Shades 68 | Weight 28.4 g | Withdrawn |
| G Shades A-2 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 53 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-3.5 | Weight 28.4 g | Withdrawn |
| Extended Range B Shades 94 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 66 | Weight 28.4 g | Withdrawn |
| G Shades C-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 77 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-2 | Weight 28.4 g | Withdrawn |
| G Shades B-3 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain White | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Dark | Weight 113.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| G Shades A-1 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-2 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake Extended Range B Shades 91 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 69 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B Shades 62 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 95 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades B-3 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Medium | Weight 10 g | Withdrawn |
| Paint-O-Pake C-1 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-2 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake D-4 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Pink | Weight 113.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 63 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B Shades 70 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Paint-O-Pake A-1 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 63 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Yellow | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-4 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Pink | Weight 10 g | Withdrawn |
| B Shades 68 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake Extended Range B Shades 94 | Weight 28.4 g | Withdrawn |
| Overglaze | Weight 28.4 g | Withdrawn |
| G Shades A-3.5 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 91 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Violet | Weight 10 g | Withdrawn |
| Opaceous Body A-0 | Weight 28.4 g | Withdrawn |
| G Shades C-3 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Extra Light | Weight 28.4 g | Withdrawn |
| Extended Range B Shades 92 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Orange | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 96 | Weight 28.4 g | Withdrawn |
| Opaceous Body C-4 | Weight 28.4 g | Withdrawn |
| Universal Tissue Tint Light | Weight 28.4 g | Withdrawn |
| G Shades B-3 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Yellow | Weight 10 g | Withdrawn |
| Paint-O-Pake B Shades 59 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-3 | Weight 113.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-1 | Weight 28.4 g | Withdrawn |
| Body Modifiers, Hue Modifiers | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 51 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| B Shades 59 | Weight 28.4 g | Withdrawn |
| Incisal Porcelain Medium | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Paint-O-Pake Extended Range B Shades 53 | Weight 28.4 g | Withdrawn |
| G Shades A-2 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 52 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 59 | Weight 28.4 g | Withdrawn |
| Opaceous Body B-1 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Body Porcelains B-CO 91 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Weight 10 g | Withdrawn |
| Paint-O-Pake B-3 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| Body Modifiers, Hue Modifiers | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-4 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Opaceous Body D-3 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades C-2 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-3 | Weight 28.4 g | Withdrawn |
| Hue Modifiers | Weight 28.4 g | Withdrawn |
| Tissue Tint Add-On Bubblegum | Weight 10 g | Withdrawn |
| Paint-O-Pake B-CO Shades 66 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-3 | Weight 113.4 g | Withdrawn |
| Body Porcelains B-CO 81 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-4 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Body Porcelains B-CO 94 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Incisal Porcelain White | Weight 113.4 g | Withdrawn |
| Tissue Tint Add-On Raspberry | Weight 10 g | Withdrawn |
| Paint-O-Pake C-1 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake B-4 | Weight 28.4 g | Withdrawn |
| B Shades 67 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 62 | Weight 28.4 g | Withdrawn |
| Bleached Shades Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Paint-O-Pake B-CO Shades 54 | Weight 28.4 g | Withdrawn |
| Tissue Tint Add-On Salmon | Weight 10 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Paint-O-Pake B Shades 64 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| G Shades A-3 | Weight 113.4 g | Withdrawn |
| Extended Range B Shades 96 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Opaceous Body C-3 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 83 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| Paint-O-Pake C-3 | Weight 113.4 g | Withdrawn |
| G Shades C-1 | Weight 113.4 g | Withdrawn |
| Hue Modifiers | Weight 28.4 g | Withdrawn |
| Paint-O-Pake C-3 | Weight 28.4 g | Withdrawn |
| Hue Modifiers | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Blue | Weight 10 g | Withdrawn |
| Paint-O-Pake B Shades 65 | Weight 28.4 g | Withdrawn |
| Universal Tissue Tint Medium | Weight 28.4 g | Withdrawn |
| G Shades D-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake D-3 | Weight 28.4 g | Withdrawn |
| B Shades 82 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake C-4 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-1 | Weight 28.4 g | Withdrawn |
| Body Modifiers, Hue Modifiers | Weight 28.4 g | Withdrawn |
| Tissue Tint Add-On Toffee | Weight 10 g | Withdrawn |
| Opaceous Body A-2 | Weight 28.4 g | Withdrawn |
| Opaceous Body D-2 | Weight 28.4 g | Withdrawn |
| B Shades 70 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Light | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains Ivory | Weight 28.4 g | Withdrawn |
| B Shades 69 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Pink | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Add-On Dark | Weight 10 g | Withdrawn |
| Opal Incisal Porcelains Violet | Weight 28.4 g | Withdrawn |
| B Shades 62 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake C-2 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades A-3 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| G Shades C-2 | Weight 113.4 g | Withdrawn |
| G Shades A-3 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| G Shades D-2 | Weight 28.4 g | Withdrawn |
| Opaceous Body B-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 81 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake D-2 | Weight 113.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Extended Range B Shades 51 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Weight 10 g | Withdrawn |
| Universal Tissue Tint Dark | Weight 28.4 g | Withdrawn |
| G Shades C-1 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Orange | Weight 10 g | Withdrawn |
| Paint-O-Pake A-4 | Weight 113.4 g | Withdrawn |
| Body Porcelains B-CO 77 | Weight 28.4 g | Withdrawn |
| Modifier Fluid | Total Volume 5 ml | Withdrawn |
| Opaceous Body B-0 | Weight 28.4 g | Withdrawn |
| G Shades A-0 | Weight 28.4 g | Withdrawn |
| G Shades A-1 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake Extended Range B Shades 93 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Paint-O-Pake A-1 | Weight 113.4 g | Withdrawn |
| G Shades A-3.5 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 55 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake Extended Range B Shades 95 | Weight 28.4 g | Withdrawn |
| Extended Range B Shades 95 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-2 | Weight 113.4 g | Withdrawn |
| Paint-O-Pake Extended Range B Shades 54 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| G Shades C-2 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 94 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B Shades 77 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| Body Porcelains B-CO 92 | Weight 28.4 g | Withdrawn |
| B Shades 64 | Weight 28.4 g | Withdrawn |
| Opaceous Body B-3 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake Extended Range B Shades 55 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake D-4 | Weight 28.4 g | Withdrawn |
| Body Modifiers, Hue Modifiers | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains White | Weight 10 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Paint-O-Pake Extended Range B Shades 56 | Weight 28.4 g | Withdrawn |
| G Shades B-4 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Transparent | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Orange | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Body Porcelains B-CO 54 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Body Porcelains B-CO 67 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-3 | Weight 28.4 g | Withdrawn |
| Chroma Rich Body Porcelains A-1 | Weight 113.4 g | Withdrawn |
| Extended Range B Shades 55 | Weight 28.4 g | Withdrawn |
| High Value Paint-O-Pake G Shades D-2 | Weight 28.4 g | Withdrawn |
| Extended Range B Shade 91 | Weight 28.4 g | Withdrawn |
| B Shades 66 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 59 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-2 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 2 ml | Withdrawn |
| Incisal Porcelain Yellow | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Dark | Weight 10 g | Withdrawn |
| Low-Temp Glaze | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-1 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-0 | Weight 28.4 g | Withdrawn |
| Chroma Modifiers | Weight 28.4 g | Withdrawn |
| Hue Modifiers | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 85 | Weight 28.4 g | Withdrawn |
| Ultra-Pake® | Total Volume 3.5 ml | Withdrawn |
| High Value Paint-O-Pake G Shades C-3 | Weight 28.4 g | Withdrawn |
| Body Porcelains B-CO 56 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake A-4 | Weight 28.4 g | Withdrawn |
| Paint-O-Pake B-CO Shades 92 | Weight 28.4 g | Withdrawn |
| G Shades A-4 | Weight 28.4 g | Withdrawn |
| Opal Incisal Porcelains Light | Weight 28.4 g | Withdrawn |
| G Shades B-1 | Weight 113.4 g | Withdrawn |
| G Shades D-3 | Weight 113.4 g | Withdrawn |
| Incisal Porcelain Medium | Weight 113.4 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.