Super Seal
Potassium oxalate based film forming acid resistant liner and desensitizer.
1manufacturer
5catalogue numbers in this listing
1510(k) clearance
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 | Phoenix Dental, Inc., United States |
|---|---|
| FDA product code | EJK |
| Device type | Liner, Cavity, Calcium Hydroxide |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3250 |
| Record published | 2016-09-16 |
| Record revised | 2022-06-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature. Do not refrigerate. |
| Sizes | Total volume 1 to 10 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100295 | Total Volume 5 ml | In distribution |
| 100291 | Total Volume 1 ml | In distribution |
| 100298 | Total Volume 8 ml | In distribution |
| 100294 | Total Volume 4 ml | In distribution |
| 100290 | Total Volume 10 ml | 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 |
| Cal LC | Prevest Denpro Limited | 4 |
| AxioCAL LC | Axiodent Inc. | 4 |
| Ultra-Blend Plus | Ultradent Products Inc. | 4 |
| AxioCAL | Axiodent Inc. | 4 |
| UltraCal XS | Ultradent Products Inc. | 4 |
Showing 12 of 84. All products under Liner, Cavity, Calcium Hydroxide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983477 | 1998-12-22 |
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.