Identity
- Trade Name
- BONDPRO™ LIGHT ACTIVATED ADHES 5gm SYRINGE FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- 1x 5gm adhesive syringe. A unique light activated composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel. FDA UDI
- Model / Reference
- M972-01 FDA UDI
- Description
- 1x 5gm adhesive syringe. A unique light activated composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886000670 FDA UDI
- 510(k) Number
- K981036 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Orthodontic bracket adhesive 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
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: Orthodontic bracket adhesive
BONDPRO™ LIGHT ACTIVATED ADHES 5gm SYRINGE by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket adhesive.
- Opal Bond — ULTRADENT PRODUCTS, INC. · Class I
- ORTHOSOURCE — Ortho Source
- Resilience — ORTHO TECHNOLOGY, INC. · Class II
- Illuminate — Ortho Organizers, Inc. · Class II
- Novocol GRANITEC PRIMER 9ML — Septodont · Class II
- Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Cleared under the same submission
K981036 also covers:
- BONDPRO™ ETCHANT GEL 1-12g KIT — G&H Wire Company, Inc.
- 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™ 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 399908f0-022f-4cb7-ab99-3ea6712754a1 35 fields · synced Jun 8, 2026