Identity
- Trade Name
- MASTER-FIL FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Master-Fil BULKFILL Universal LC Composite FDA UDI
- Model / Reference
- 19-602 FDA UDI
- Description
- Master-Fil BULKFILL Universal LC Composite FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816526022088 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-Fil by Dentonics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Llis — Dentscare Ltda · Class II
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- 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 6c4a5942-2f75-4ac8-bb65-70304bef93a3 34 fields · synced May 30, 2026