Identity
- Trade Name
- Nu Shield FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing FDA UDI
- Device Name
- Nu Shield 0.4 gram Unit Dose 100 Packet FDA UDI
- Model / Reference
- 0.4 gram - 100 pack FDA UDI
- Description
- Nu Shield 0.4 gram Unit Dose 100 Packet FDA UDI
Identifiers
- Catalog Number
- 0974 FDA UDI
- Primary DI / UDI-DI
- B77209740 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 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 coating, tooth-desensitizing
Nu Shield by Nu Radiance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental coating, tooth-desensitizing.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Caramel — Preventech · Class II
- Varnish, Bulk, Oral-B, Bubblegum 1800 — YOUNG DENTAL MANUFACTURING I, LLC · Class II
- VOCO Profluorid Varnish — VOCO GmbH · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- IRIS — BENCO DENTAL SUPPLY CO. · Class II
- Pulp Canal Sealer — KERR ITALIA SRL · Class IIa
- MICROPRIME — DANVILLE MATERIALS, LLC · 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 c4022366-077e-4056-82db-2287da52c605 35 fields · synced May 30, 2026