Identity
- Trade Name
- BONDPRO™ ETCHANT GEL 1-12g KIT FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- 37% phosphoric acid gel. A medium viscosity etchant gel used for etching enamel and denin prior to bonding procedures. Kit contains 1x 12gm syringe, disposable mixing tips, and instructions. FDA UDI
- Model / Reference
- M981K-01 FDA UDI
- Description
- 37% phosphoric acid gel. A medium viscosity etchant gel used for etching enamel and denin prior to bonding procedures. Kit contains 1x 12gm syringe, disposable mixing tips, and instructions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886000731 FDA UDI
- 510(k) Number
- K981036 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 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
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
Yes
FDA UDI
Category: Dental etching solution
BONDPRO™ ETCHANT GEL 1-12g KIT by G&H Wire Company, 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
K981036 also covers:
- BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT — G&H Wire Company, Inc.
- BONDPRO™ LIGHT ACTIVATED ADHES 1-5gm SYRINGE KIT — G&H Wire Company, Inc.
- BONDPRO™ LIGHT ACTIVATED ADHES 5gm SYRINGE — G&H Wire Company, Inc.
- BONDPRO™ ONE STEP ADHESIVE KIT 1-5gm SYRINGE — G&H Wire Company, Inc.
- BONDPRO™ ONE STEP ADHESIVE KIT 4-5gm SYRINGES — G&H Wire Company, Inc.
- BONDPRO™ PORCELAIN ENHANCER 10cc — G&H Wire Company, 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
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI 98a61310-cc8b-4d67-bed8-8f76521b8723 36 fields · synced Jun 8, 2026