Identity
- Trade Name
- Alpha-Crown® FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns and bridges with ease and convenience. The static mixing tip provides automatic mixing from the dual chambered cartridge to greatly reduce in-office procedure time. The Bix-acryl material is very durable, color stable, and water resistant. The greater flexibility facilitates deformation free removal of the material from the patient's mouth. Alpha-Crown® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 74g Cartridge (Shade A3.5), 10 Automix Tips FDA UDI
- Model / Reference
- 113.0008.002 FDA UDI
- Description
- Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns and bridges with ease and convenience. The static mixing tip provides automatic mixing from the dual chambered cartridge to greatly reduce in-office procedure time. The Bix-acryl material is very durable, color stable, and water resistant. The greater flexibility facilitates deformation free removal of the material from the patient's mouth. Alpha-Crown® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 74g Cartridge (Shade A3.5), 10 Automix Tips FDA UDI
Identifiers
- Catalog Number
- 113.0008.002 FDA UDI
- Primary DI / UDI-DI
- D73511300080020 FDA UDI
- 510(k) Number
- K960122 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
Yes
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: Temporary dental crown/bridge resin
Alpha-Crown® by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge resin.
- JET TOOTH SHADE POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- UNIFAST™ — Gc America Inc. · Class II
- MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
- DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
- PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- tempofit premium BL — DETAX GmbH · Class II
- YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II
- YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II
Cleared under the same submission
K960122 also covers:
- Alpha-Crown® — Dental Technologies, Inc.
- Alpha-Crown® — Dental Technologies, Inc.
- Alpha-Crown® — Dental Technologies, Inc.
- Alpha-Crown® — Dental Technologies, Inc.
- SCOTT'S SELECT TEMPORARY C&B STD PKG A1 — SCOTT'S DENTAL SUPPLY L.L.C.
- SCOTT'S SELECT TEMPORARY C&B STD PKG A2 — SCOTT'S DENTAL SUPPLY L.L.C.
- SCOTT'S SELECT TEMPORARY C&B STD PKG A3 — SCOTT'S DENTAL SUPPLY L.L.C.
- SCOTT'S SELECT TEMPORARY C&B STD PKG A3.5 — SCOTT'S DENTAL SUPPLY L.L.C.
- SCOTT'S SELECT TEMPORARY C&B STD PKG B1 — SCOTT'S DENTAL SUPPLY L.L.C.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Technologies, Inc.
Sources (1)
- FDA UDI 63038da8-329c-4093-920b-ac1f6c2ed959 36 fields · synced Jun 9, 2026