Identity
- Trade Name
- Temp Fix FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- Temp Fix Disc, 98 X 20mm, Shade A1 FDA UDI
- Model / Reference
- 1017-20 FDA UDI
- Description
- Temp Fix Disc, 98 X 20mm, Shade A1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8701017201 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
Temp Fix by Harvest Dental Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Temporary dental crown/bridge resin.
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- 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
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 II | Pending data |
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Manufacturer
- Manufacturer
- Harvest Dental Products Llc
Sources (1)
- FDA UDI 565ea2c3-d44a-4f4c-ab84-02543658f7c0 34 fields · synced May 30, 2026