Identity
- Trade Name
- ALPHA-DENT® Etchant Liquid FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- ALPHA-DENT® Etchant Liquid is a 37% phosphoric acid etchant designed for use on both dentin and enamel. All formulas rinse away clean without leaving any residue. Available in blue or green color. Kit Contains: 1 x 7ml Bottle (Green) FDA UDI
- Model / Reference
- 503.0203.001 FDA UDI
- Description
- ALPHA-DENT® Etchant Liquid is a 37% phosphoric acid etchant designed for use on both dentin and enamel. All formulas rinse away clean without leaving any residue. Available in blue or green color. Kit Contains: 1 x 7ml Bottle (Green) FDA UDI
Identifiers
- Catalog Number
- 503.0203.001 FDA UDI
- Primary DI / UDI-DI
- D73550302030010 FDA UDI
- 510(k) Number
- K984503 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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 etching solution
ALPHA-DENT® Etchant Liquid by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
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- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- ETCHANT — Pulpdent Corporation · Class II
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- GC CERAMIC PRIMER II — Gc America Inc. · Class II
Cleared under the same submission
K984503 also covers:
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Etchant Liquid — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Light Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- ALPHA-DENT® Self Cure Bonding Adhesive — Dental Technologies, Inc.
- Alpha-Bond® — Dental Technologies, Inc.
- Alpha-Bond® Activator — Dental Technologies, Inc.
- Alpha-Bond® SE — Dental Technologies, 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 2fb2c4b0-47d7-43d2-babd-3d6a50f413fe 37 fields · synced Jun 9, 2026