Radica®
20 catalogue numbers from Dentin A4, listed by Dentsply LLC, United States, under Coating, Filling Material, Resin. 1 manufacturer in China is registered for this product code.
1manufacturer
20catalogue 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 | Dentsply LLC, 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, 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 |
| Packaging | Pack of 12 |
| Sizes | Weight 2 to 5 g; total volume 0.5 Fluid Ounce |
| Distribution end date | 2022-05-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Dentin A4 | Weight 5 g | Withdrawn |
| Dentin A2 | Weight 5 g | Withdrawn |
| Dentin C3 | Weight 5 g | Withdrawn |
| Stain Brown | Weight 2 g | Withdrawn |
| Dentin B2 | Weight 5 g | Withdrawn |
| Stain White | Weight 2 g | Withdrawn |
| Dentin B4 | Weight 5 g | Withdrawn |
| Sealer | Total Volume 0.5 Fluid Ounce | Withdrawn |
| Dentin C1 | Weight 5 g | Withdrawn |
| Dentin & Enamel Assortment Kit | Weight 5 g | Withdrawn |
| Dentin A3 | Weight 5 g | Withdrawn |
| Dentin C2 | Weight 5 g | Withdrawn |
| Dentin C4 | Weight 5 g | Withdrawn |
| Dentin D4 | Weight 5 g | Withdrawn |
| Dentin D2 | Weight 5 g | Withdrawn |
| Stain Olive | Weight 2 g | Withdrawn |
| Dentin D3 | Weight 5 g | Withdrawn |
| Dentin i2 | Weight 5 g | Withdrawn |
| Dentin RD-001 | Weight 5 g | Withdrawn |
| Dentin B3 | Weight 5 g | Withdrawn |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 |
| 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 |
| 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 |
|---|---|
| K070306 | 2007-03-22 |
| K850641 | 1985-03-18 |
| K840751 | 1984-05-11 |
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.