Identity
- Trade Name
- FRIGI-DENT FDA UDI
- Generic Name
- Cryogenic spray, dental FDA UDI
- Device Name
- FRIGI-DENT - CASE OF 25 CANS AND STRAWS FDA UDI
- Model / Reference
- EFD140ACS FDA UDI
- Description
- FRIGI-DENT - CASE OF 25 CANS AND STRAWS FDA UDI
Identifiers
- Catalog Number
- EFD140ACS FDA UDI
- Primary DI / UDI-DI
- 00841494103217 FDA UDI
- 510(k) Number
- K954703 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryogenic spray, dental FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cryogenic spray, dental
Frigi-Dent by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryogenic spray, dental.
- Health-Tec/DHP Refrigerant Spray — Dental Health Products Inc · Class II
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- WINTERGREEN FREEZE SPRAY — ECOTEC MANUFACTURING · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Dental City — ICP, INC. · Class II
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class II
Cleared under the same submission
K954703 also covers:
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
- Cynosure, LLC
Sources (1)
- FDA UDI 9a24e6fa-b114-4625-b5fb-358003b01669 35 fields · synced Jun 8, 2026