Alpha-Seal®
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal…
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an “invisible” sealant. Kit Contains: 3 x 1g Sealant Syringe (Opaque White), 10 Dispensing Tips, 1 x 4g Alpha-Etch® 37 Syringe, 10 Dispensing Tips, 20 Disposable Brushes
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
Record
| Listed by | Dental Technologies, Inc., United States |
|---|---|
| FDA product code | EBC |
| Device type | Sealant, Pit And Fissure, And Conditioner |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3765 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K924635 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 401.0010.002 | In distribution | |
| 401.0103.002 | In distribution | |
| 401.0303.002 | In distribution | |
| 401.0009.002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltraSeal XT | Ultradent Products Inc. | 22 |
| SciPharm Pit & Fissure Sealer Bonding Agent | Scientific Pharmaceuticals, Inc. | 20 |
| Orthosource | Orthosource, Inc. | 20 |
| Visalys Fill | Kettenbach Gmbh & Co KG | 14 |
| Riva Protect | SDI Ltd. | 14 |
| Venus Diamond Flow | Kulzer SRL | 9 |
| Conseal | SDI Ltd. | 9 |
| Delton® | Dentsply Professional | 9 |
| Helioseal Clear F F Plus | Ivoclar Vivadent Aktiengesellschaft | 8 |
| Patterson® | Patterson Dental Supply, Inc. | 8 |
| Clinpro™ | 3M Company | 7 |
| Visalys Flow | Kettenbach Gmbh & Co KG | 7 |
Showing 12 of 133. All products under Sealant, Pit And Fissure, And Conditioner
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.