Identity
- Trade Name
- MASTER-DENT FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Core Build-Up, Paste-Paste, 14gm Base Paste & 14gm Catalyst Paste, White FDA UDI
- Model / Reference
- 19-000-W FDA UDI
- Description
- Core Build-Up, Paste-Paste, 14gm Base Paste & 14gm Catalyst Paste, White FDA UDI
Identifiers
- Catalog Number
- 19-000-W FDA UDI
- Primary DI / UDI-DI
- 00816526021159 FDA UDI
- 510(k) Number
- K832781 FDA UDI
- GMDN Term
- Dental composite resin 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: Dental composite resin
Master-Dent by Dentonics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
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 28167952-0736-4033-8193-740d9d522fde 36 fields · synced Jun 8, 2026