DuraFinish™
All-Cure DuraFinish™ Composite Glaze
1manufacturer
4catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
Record
| Listed by | Parkell, Inc., United States |
|---|---|
| FDA product code | EBD |
| Device type | Coating, Filling Material, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2024-01-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature. Storage at low temperatures may cause phase separation. |
| Distribution end date | 2021-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S296 | In distribution | |
| S295 | Withdrawn | |
| S295 | Withdrawn | |
| S296 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ID Lightcure System | ID Korea Co., Ltd. | 63 |
| Minute Stain | Taub Products | 56 |
| Optiglaze™ | GC America Inc. | 44 |
| Rodin | PAC-Dent Inc. | 39 |
| Renamel® Flowable Microfill | Deltamed Gmbh | 27 |
| Vita Akzent® LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 27 |
| Renamel® Flowable Microfill | Cosmedent, Inc. | 26 |
| Radica® | Dentsply LLC | 20 |
| SciPharm Support Self Cured Core Build-Up Restorative Reverse | Scientific Pharmaceuticals, Inc. | 18 |
| Renamel® Flowable Microhybrid | Cosmedent, Inc. | 16 |
| Glaze | Taub Products | 14 |
| Signum matrix | Kulzer SRL | 14 |
Showing 12 of 100. All products under Coating, Filling Material, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080549 | 2008-05-13 |
| K040599 | 2004-04-09 |
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.