Renamel® Flowable Microhybrid
16 catalogue numbers from 7011A4, listed by Cosmedent, Inc., United States, under Coating, Filling Material, Resin. 1 manufacturer in China is registered for this product code.
1manufacturer
16catalogue numbers in this listing
3510(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 | Cosmedent, Inc., United States |
|---|---|
| FDA product code | EBD |
| Device type | Coating, Filling Material, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3310 |
| Establishment | Repacker / relabeller |
| 510(k) | K222435 |
| Record published | 2016-09-22 |
| Record revised | 2022-12-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7011A4 | In distribution | |
| 7011B2 | In distribution | |
| 7011C2 | In distribution | |
| 7011A3 | In distribution | |
| 7011A1 | In distribution | |
| 7011C4 | In distribution | |
| 701A35 | In distribution | |
| 7011B3 | In distribution | |
| 701MWO | In distribution | |
| 7011D3 | In distribution | |
| 7011C3 | In distribution | |
| 7011A2 | In distribution | |
| 7011B1 | In distribution | |
| 70110W | In distribution | |
| 7011MI | In distribution | |
| 7011CO | In distribution |
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 |
| Glaze | Taub Products | 14 |
| Signum matrix | Kulzer SRL | 14 |
| Minute Stain – L.M.D. Elixirs | Taub Products | 12 |
Showing 12 of 100. All products under Coating, Filling Material, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K011239 | 2002-02-14 |
| K980298 | 1998-03-09 |
| K974494 | 1998-02-10 |
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.