Identity
- Trade Name
- Dental Etchant (Enamel Conditioner), 1kg Bottle FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- Etch Gel-available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips • Easy to wash off • Economical • Colored for precise application • Excellent wetting characteristics • Non-drying • Direct to tooth application with disposable luer-lock tips • Refillable applicator syringes FDA UDI
- Model / Reference
- 0054 FDA UDI
- Description
- Etch Gel-available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips • Easy to wash off • Economical • Colored for precise application • Excellent wetting characteristics • Non-drying • Direct to tooth application with disposable luer-lock tips • Refillable applicator syringes FDA UDI
Identifiers
- Catalog Number
- 0054 FDA UDI
- Primary DI / UDI-DI
- D83600540 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Dental etching solution
Dental Etchant (Enamel Conditioner), 1kg Bottle by Dent Zar, 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
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
- Dent Zar, Inc.
Sources (1)
- FDA UDI 3632e5b4-d576-4715-981c-96547e6b3754 34 fields · synced Jun 8, 2026