Identity
- Trade Name
- MASTER-DENT FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- Ultimate Bond, Light Cure Adhesive, 7gm Bottle FDA UDI
- Model / Reference
- 19-215 FDA UDI
- Description
- Ultimate Bond, Light Cure Adhesive, 7gm Bottle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816526020398 FDA UDI
- 510(k) Number
- K843098 FDA UDI
- GMDN Term
- Dentine adhesive FDA UDI
Classification
- 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
No
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
No
FDA UDI
Category: Dentine adhesive
Master-Dent by Dentonics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentine adhesive.
- SEPTODONT HZ IMAGE MH COMP L/C SYR KIT — Septodont · Class II
- SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Peak Universal Bond — ULTRADENT PRODUCTS, INC. · Class II
- E-ON — BENCO DENTAL SUPPLY CO. · Class II
- PermaFlo DC — ULTRADENT PRODUCTS, INC. · Class II
- Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International · Class II
- SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Cleared under the same submission
K843098 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dentonics, Inc.
Sources (1)
- FDA UDI 4aacaf53-00a8-40b2-9ee4-aeac9abde0db 35 fields · synced May 30, 2026