Identity
- Trade Name
- Hygenic FDA UDI
- Generic Name
- Cryogenic spray, dental FDA UDI
- Device Name
- Endo-Ice Refrigerant Spray FDA UDI
- Model / Reference
- H05032 FDA UDI
- Description
- Endo-Ice Refrigerant Spray FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661H050320 FDA UDI
- 510(k) Number
- K930764 FDA UDI
- FDA Product Code
- EAT FDA UDI
- GMDN Term
- Cryogenic spray, dental FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1720 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
No
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: Cryogenic spray, dental
Hygenic by Coltene/Whaledent Inc. — 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
- Health-Tec Endo Refrigerant Spray — Dental Health Products Inc · Class II
- RMH3 Dental — ECOTEC MANUFACTURING · Class II
- Arctic Blast — MARIE REIKO INC · Class II
- 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
K930764 also covers:
- Burkhart Polar Breeze Refrigerant Spray 6oz — BURKHART DENTAL SUPPLY CO., THE
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- FROST ENDO SPRAY — DARBY DENTAL SUPPLY, LLC
- Henry Schein — HENRY SCHEIN, INC.
- Dental City — ICP, INC.
- PATTERSON — PATTERSON DENTAL SUPPLY, INC.
- PATTERSON — PATTERSON DENTAL SUPPLY, INC.
- ENDO-SAVER ICE REFRIGERANT SPRAY 10oz CAN — SCOTT'S DENTAL SUPPLY L.L.C.
- Chill™ refrigerant spray — Safco Dental Supply
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
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 6137c66f-9bb9-4380-b67a-c221ed891b08 36 fields · synced Jun 9, 2026