Identity
- Trade Name
- MASTER-DENT FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Temporary Crown and Bridge Material, Shade A1 1 X 50ml Cartridge w/ Tips FDA UDI
- Model / Reference
- 60-203 FDA UDI
- Description
- Temporary Crown and Bridge Material, Shade A1 1 X 50ml Cartridge w/ Tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816526020336 FDA UDI
- 510(k) Number
- K041886 FDA UDI
- GMDN Term
- Temporary dental crown/bridge 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: Temporary dental crown/bridge
Master-Dent by Dentonics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- IDODENTINE — UNION DENTAL SA · Class II
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Cleared under the same submission
K041886 also covers:
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- SciPharm Sci-Span Crown and Bridge Material & Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Sci-Span Crown and Bridge Material & Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Sci-Span Crown and Bridge Material & Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Sci-Span Crown and Bridge Material & Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Sci-Span Crown and Bridge Material & Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Sci-Span Crown and Bridge Material & Restorative — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Sci-Span Crown and Bridge Material & Restorative — SCIENTIFIC PHARMACEUTICALS, 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dentonics, Inc.
Sources (1)
- FDA UDI fa76384d-9b4c-4703-81c9-cab0df1ca94e 35 fields · synced Jun 8, 2026