Identity
- Trade Name
- Alpha-Etch® 37 FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- Alpha-Etch® 37 is a 37% phosphoric acid etchant designed for use on both dentin and enamel. The ideal viscosity of the gel formula stays where placed and will not flow onto exposed surrounding tissue. All formulas rinse away clean without leaving any residue. Available in blue and green color. Kit Contains: 1 x 12g Syringe (Blue), 20 Syringe Tips FDA UDI
- Model / Reference
- 501.0103.002 FDA UDI
- Description
- Alpha-Etch® 37 is a 37% phosphoric acid etchant designed for use on both dentin and enamel. The ideal viscosity of the gel formula stays where placed and will not flow onto exposed surrounding tissue. All formulas rinse away clean without leaving any residue. Available in blue and green color. Kit Contains: 1 x 12g Syringe (Blue), 20 Syringe Tips FDA UDI
Identifiers
- Catalog Number
- 501.0103.002 FDA UDI
- Primary DI / UDI-DI
- D73550101030020 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-Etch® 37 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
- Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
- DC Keramik Ätzgel — PRISMAN GmbH · Class I
- MASTER-DENT — DENTONICS, INC.
- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- 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® 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.
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 5a3f5c00-e4b6-41ac-ac17-96ffdfb5894a 37 fields · synced Jun 9, 2026