Dentsply® Repair Material
Contains 454 grams of DENTSPLY Repair Material Light Fibered, one (1) 21 gram bottle of DENTSPLY Repair Material Pink Free-Flow, and two (2) 175 milliliter bottles of DENTSPLY Repair…
Contains 454 grams of DENTSPLY Repair Material Light Fibered, one (1) 21 gram bottle of DENTSPLY Repair Material Pink Free-Flow, and two (2) 175 milliliter bottles of DENTSPLY Repair Material Liquid
14manufacturers in China registered for this device type
23catalogue numbers in this listing
18510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-01-31 |
| Record revised | 2024-06-03 (version 6) |
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 |
| Packaging | Pack of 4 |
| Sizes | Weight 21 to 1815 g; total volume 58 to 946 ml |
| Distribution end date | 2024-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Bulk Powder | Weight 1815 g | Withdrawn |
| Powder | Weight 21 g | Withdrawn |
| Labpak Refill Pink | Weight 454 g | Withdrawn |
| Labpak Kit Pink Fibered | Weight 21 g | Withdrawn |
| Powder | Weight 21 g | Withdrawn |
| Labpak Kit Pink | Weight 21 g | Withdrawn |
| Powder | Weight 21 g | Withdrawn |
| Lab Powder | Weight 454 g | Withdrawn |
| Liquid | Total Volume 175 ml | Withdrawn |
| Powder | Weight 21 g | Withdrawn |
| Labpak Kit Light Fibered | Weight 454 g | Withdrawn |
| Labpak Refill Pink Fibered | Weight 454 g | Withdrawn |
| Labpak Refill Pink Free-Flow | Weight 454 g | Withdrawn |
| Bulk Powder | Weight 1815 g | Withdrawn |
| Lab Powder | Weight 454 g | Withdrawn |
| Bulk Powder | Weight 1815 g | Withdrawn |
| Starter Kit | Withdrawn | |
| Lab Powder | Weight 454 g | Withdrawn |
| Bulk Powder | Weight 1815 g | Withdrawn |
| Lab Powder | Weight 454 g | Withdrawn |
| Liquid | Total Volume 58 ml | Withdrawn |
| Liquid | Total Volume 946 ml | Withdrawn |
| Labpak Refill Light Fibered | Weight 454 g | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072713 | 2007-10-12 |
| K061580 | 2006-07-28 |
| K032892 | 2003-09-26 |
| K011560 | 2001-07-12 |
| K992956 | 1999-10-06 |
| K972573 | 1997-09-16 |
| K964040 | 1996-12-06 |
| K952351 | 1995-07-07 |
| K926406 | 1993-03-31 |
| K905702 | 1991-04-29 |
| K895742 | 1989-12-18 |
| K882482 | 1988-08-12 |
| K863324 | 1986-09-05 |
| K834409 | 1984-02-27 |
| K831647 | 1983-06-30 |
| K800400 | 1980-03-12 |
| K792042 | 1979-11-30 |
| K780786 | 1978-06-14 |
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.