Identity
- Trade Name
- Alpha-Flow® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Alpha-Flow® is a radiopaque fluoride containing light cure resin-based micro-hybrid flowable composite. The specially formulated materials incorporates both a nano-sized filler for increased flexibility and superior polishability and a 0.7 micron filler for excellent strength and wear resistance. This special combination provides a material with extreme versatility for use in a wide range of procedures, including Class III and V cavity figurations and small Class I and II restorations. Alpha-flow® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 1 x 1.5g Composite syringe (Shade A1), 5 Syringe Applicator Tips FDA UDI
- Model / Reference
- 103.0102.002 FDA UDI
- Description
- Alpha-Flow® is a radiopaque fluoride containing light cure resin-based micro-hybrid flowable composite. The specially formulated materials incorporates both a nano-sized filler for increased flexibility and superior polishability and a 0.7 micron filler for excellent strength and wear resistance. This special combination provides a material with extreme versatility for use in a wide range of procedures, including Class III and V cavity figurations and small Class I and II restorations. Alpha-flow® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 1 x 1.5g Composite syringe (Shade A1), 5 Syringe Applicator Tips FDA UDI
Identifiers
- Catalog Number
- 103.0102.002 FDA UDI
- Primary DI / UDI-DI
- D73510301020020 FDA UDI
- 510(k) Number
- K960667 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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 composite resin
Alpha-Flow® by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Llis — Dentscare Ltda · Class II
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Cleared under the same submission
K960667 also covers:
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 cfd58e3e-b68c-4a0c-b3f7-8307b32ab2bf 37 fields · synced Jun 9, 2026