Identity
- Trade Name
- Alpha-Seal® FDA UDI
- Generic Name
- Dental pit/fissure sealant FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 401.0009.002 FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- 401.0009.002 FDA UDI
- Primary DI / UDI-DI
- D73540100090020 FDA UDI
- 510(k) Number
- K924635 FDA UDI
- FDA Product Code
- EBC FDA UDI
- GMDN Term
- Dental pit/fissure sealant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3765 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental pit/fissure sealant
Alpha-Seal® by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K924635 also covers:
- ALPHA-DENT® Light Cure Pit & Fissure Sealant — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Pit & Fissure Sealant — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Pit & Fissure Sealant — Dental Technologies, Inc.
- Alpha-Seal® — Dental Technologies, Inc.
- Alpha-Seal® — Dental Technologies, Inc.
- Alpha-Seal® — Dental Technologies, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dental Technologies, Inc.
Sources (1)
- FDA UDI 61599234-a586-4ad6-9a40-1bf66d0fed12 37 fields · synced Jun 9, 2026