Identity
- Trade Name
- Burkhart Polar Breeze Refrigerant Spray 6oz FDA UDI
- Generic Name
- Cryogenic spray, dental FDA UDI
- Model / Reference
- 72720585 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854212006561 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
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: Cryogenic spray, dental
Burkhart Polar Breeze Refrigerant Spray 6oz by Burkhart Dental Supply Co., The — 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:
- Hygenic — Coltene/Whaledent Inc.
- 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 |
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Manufacturer
- Manufacturer
- Burkhart Dental Supply Co., The
Sources (1)
- FDA UDI 33efff10-f4a8-4b6e-8997-afaeb47f6760 34 fields · synced Jun 8, 2026