Identity
- Trade Name
- ALPHA-DENT® Plastic Conditioner FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- ALPHA-DENT® Plastic Conditioner prepares plastic brackets and buttons for direct bonding. Application of conditioner prior to adhesive application will provide an enhanced bond between the bracket base and the adhesive. FDA UDI
- Model / Reference
- 544.0101.001 FDA UDI
- Description
- ALPHA-DENT® Plastic Conditioner prepares plastic brackets and buttons for direct bonding. Application of conditioner prior to adhesive application will provide an enhanced bond between the bracket base and the adhesive. FDA UDI
Identifiers
- Catalog Number
- 544.0101.001 FDA UDI
- Primary DI / UDI-DI
- D73554401010010 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® Plastic Conditioner by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket adhesive.
- Opal Bond — ULTRADENT PRODUCTS, INC. · Class I
- ORTHOSOURCE — Ortho Source
- Resilience — ORTHO TECHNOLOGY, INC. · Class II
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- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Cleared under the same submission
K921044 also covers:
- ALPHA-DENT® Metal Conditioner — 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 Bracket Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® One Step Primer — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Technologies, Inc.
Sources (1)
- FDA UDI a118cadb-4052-4df8-b97f-98dbb614770f 37 fields · synced Jun 9, 2026