Identity
- Trade Name
- GEL ETCH FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- DENTAL ETCHING PREPARATORY MATERIAL FDA UDI
- Model / Reference
- 6575 BULK KIT FDA UDI
- Description
- DENTAL ETCHING PREPARATORY MATERIAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015110399 FDA UDI
- 510(k) Number
- K872569 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
No
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
Gel Etch by Temrex Corp. — 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
K872569 also covers:
- Ortho Organizers — Ortho Organizers, Inc.
- International Dental Supply Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Dental Etching Agent Bottle — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Dental Etching Agent Bottle, Non-Boxed — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Gel Etch Dental Conditioner — SCIENTIFIC PHARMACEUTICALS, 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
- Temrex Corp.
Sources (1)
- FDA UDI 05443e9e-1184-47ca-be22-7935933e3c89 34 fields · synced May 30, 2026