Identity
- Trade Name
- BioTemps FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- BioTemps NOW Milling Blocks; Bridge Block; A2 (5-pack) FDA UDI
- Model / Reference
- 70-1181-MIL0091 FDA UDI
- Description
- BioTemps NOW Milling Blocks; Bridge Block; A2 (5-pack) FDA UDI
Identifiers
- Catalog Number
- 70-1181-MIL0091 FDA UDI
- Primary DI / UDI-DI
- D745701181MIL00911 FDA UDI
- 510(k) Number
- K201683 FDA UDI
- FDA Product Code
- MQC FDA UDIEBG FDA UDIEBI FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 872.3770 FDA UDI872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Temporary dental crown/bridge resin
BioTemps by Prismatik Dentalcraft, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge resin.
- Alpha-Crown® — Dental Technologies, Inc. · Class II
- JET TOOTH SHADE POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- UNIFAST™ — Gc America Inc. · Class II
- MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
- DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
- PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- tempofit premium BL — DETAX GmbH · Class II
- YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II
Cleared under the same submission
K201683 also covers:
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
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 U | Pending data |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI 11b8109f-b606-4493-ad2c-f533e00c0193 36 fields · synced Jun 8, 2026