Teethmate™ Desensitizer
Teethmate Desensitizer reduces tooth hypersensitivity by sealing dentinal tubules and enamel microcracks. A calcium-phosphate powder and predominantly water-based liquid are mixed into a…
Teethmate Desensitizer reduces tooth hypersensitivity by sealing dentinal tubules and enamel microcracks. A calcium-phosphate powder and predominantly water-based liquid are mixed into a paste for application to the affected surface.
The applied paste transforms into hardened hydroxyapatite. This physical sealing mechanism is used on exposed dentin, after cleaning or root planing, and on dentin prepared for fillings or prosthetic restorations.
Listed Item
Introductory Set
Bleaching Applications
The material is also indicated for tooth-surface treatment before or after bleaching. Its two-part powder-and-liquid presentation prepares the sealing paste at the time of use.
Who Else Makes It
Registered in Guangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
Record
| Listed by | Kuraray Noritake Dental, Inc., United States |
|---|---|
| FDA product code | EJK |
| Device type | Liner, Cavity, Calcium Hydroxide |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3250 |
| 510(k) | K131068 |
| Record published | 2017-02-17 |
| Record revised | 2021-08-10 (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 |
|---|---|---|
| #1210-KA | In distribution | |
| #1217-KA | In distribution | |
| #1216-KA | In distribution | |
| #1215-KA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Roeko Calcium Hydroxide Plus Points | Coltène/Whaledent AG | 15 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 14 |
| Calcigel | Prevest Denpro Limited | 8 |
| TheraCal LC | Bisco, Inc. | 8 |
| Hydroxyline | Taub Products | 8 |
| GC Fuji Lining™ | GC America Inc. | 7 |
| TheraCal PT | Bisco, Inc. | 6 |
| Super Seal | Phoenix Dental, Inc. | 5 |
| Cal LC | Prevest Denpro Limited | 4 |
| AxioCAL LC | Axiodent Inc. | 4 |
| Ultra-Blend Plus | Ultradent Products Inc. | 4 |
| AxioCAL | Axiodent Inc. | 4 |
Showing 12 of 84. All products under Liner, Cavity, Calcium Hydroxide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131068 | 2013-08-27 |
| K122421 | 2012-12-11 |
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.