Identity
- Trade Name
- EdgeIce FDA UDI
- Generic Name
- Cryogenic spray, dental FDA UDI
- Device Name
- EdgeIce Refrigerant pulp vitality spray is used in dentistry for the purpose of thermo testing of tooth vitality. For professional dental use only. FDA UDI
- Model / Reference
- EDGEICE FDA UDI
- Description
- EdgeIce Refrigerant pulp vitality spray is used in dentistry for the purpose of thermo testing of tooth vitality. For professional dental use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818365020065 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 170 Gram FDA UDI
Category: Cryogenic spray, dental
EdgeIce by Edge Endo Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Edge Endo Llc
Sources (1)
- FDA UDI 4a80dcdd-5aa5-4b1c-b1bb-51d77aa4a2fb 34 fields · synced Jun 6, 2026