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ALPHA-DENT® Paste & Paste Orthodontic Adhesive
FDA UDIIdentity
- Trade Name
- ALPHA-DENT® Paste & Paste Orthodontic Adhesive FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- ALPHA-DENT® Paste & Paste Orthodontic Adhesive is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimizes bonding failures. Kit Contains: 14g Catalyst Paste, 14g Base Paste, 1x 7ml Catalyst Bracket Bonding Resin, 1 x 7ml Base Bracket Bonding Resin, 7ml Etch Liquid, Spatulas, Mixing Pads FDA UDI
- Model / Reference
- 302.0000.001 FDA UDI
- Description
- ALPHA-DENT® Paste & Paste Orthodontic Adhesive is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimizes bonding failures. Kit Contains: 14g Catalyst Paste, 14g Base Paste, 1x 7ml Catalyst Bracket Bonding Resin, 1 x 7ml Base Bracket Bonding Resin, 7ml Etch Liquid, Spatulas, Mixing Pads FDA UDI
Identifiers
- Catalog Number
- 302.0000.001 FDA UDI
- Primary DI / UDI-DI
- D73530200000010 FDA UDI
- 510(k) Number
- K930614 FDA UDI
- GMDN Term
- Orthodontic bracket adhesive FDA UDI
Classification
- 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: Orthodontic bracket adhesive
ALPHA-DENT® Paste & Paste Orthodontic Adhesive by Dental Technologies, Inc. — 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
- Illuminate — Ortho Organizers, Inc. · Class II
- Novocol GRANITEC PRIMER 9ML — Septodont · Class II
- 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
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dental Technologies, Inc.
Sources (1)
- FDA UDI 00e94042-7b70-48a0-9815-ee58d89f004c 37 fields · synced Jun 9, 2026