Identity
- Trade Name
- ALPHA-DENT® Metal Conditioner FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- ALPHA-DENT® Metal Conditioner is to be used as a primer for amalgam, gold, or stainless steel. The conditioned metal surface will provide the optimal bonding surface for the adhesive. FDA UDI
- Model / Reference
- 543.0101.001 FDA UDI
- Description
- ALPHA-DENT® Metal Conditioner is to be used as a primer for amalgam, gold, or stainless steel. The conditioned metal surface will provide the optimal bonding surface for the adhesive. FDA UDI
Identifiers
- Catalog Number
- 543.0101.001 FDA UDI
- Primary DI / UDI-DI
- D73554301010010 FDA UDI
- 510(k) Number
- K921044 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Orthodontic bracket adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 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: Orthodontic bracket adhesive
ALPHA-DENT® Metal Conditioner 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
K921044 also covers:
- ALPHA-DENT® One Step Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® One Step Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® One Step Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® One Step Primer — Dental Technologies, Inc.
- ALPHA-DENT® Plastic Conditioner — Dental Technologies, Inc.
- ALPHA-DENT® Porcelain Conditioner — Dental Technologies, Inc.
- Metal Primer — ORTHO TECHNOLOGY, INC.
- Plastic Conditioner — ORTHO TECHNOLOGY, INC.
- Porcelain Conditioner — ORTHO TECHNOLOGY, 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 d7472814-e2a8-40db-86ff-6bdedefa0581 37 fields · synced Jun 9, 2026