Identity
- Trade Name
- Nu TempCement NE FDA UDI
- Generic Name
- Dental acrylic resin FDA UDI
- Device Name
- Nu TempCement NE - One Syringe Kit FDA UDI
- Model / Reference
- One Syringe Kit FDA UDI
- Description
- Nu TempCement NE - One Syringe Kit FDA UDI
Identifiers
- Catalog Number
- 0778 FDA UDI
- Primary DI / UDI-DI
- B77207780 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental acrylic resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- 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
Yes
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 acrylic resin
Nu TempCement NE by Nu Radiance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental acrylic resin.
- PYROPLAST POWDER — AMERICAN TOOTH INDUSTRIES · Class II
- Nic Tone, MDC Dental — MDC DENTAL · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- NAMILON POWDER — AMERICAN TOOTH INDUSTRIES · Class II
- REPAIR MATERIAL — AMERICAN TOOTH INDUSTRIES · Class II
- QUARZ, MDC Dental — MDC DENTAL · Class II
- ArgenPMMA 98x14-C4 — ARGEN CORPORATION, THE · Class II
- JUSTI- PAKTO POWDER — AMERICAN TOOTH INDUSTRIES · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nu Radiance, Inc.
Sources (1)
- FDA UDI 816879cb-4838-4f82-96ca-043e4cab929c 35 fields · synced May 30, 2026