Identity
- Trade Name
- DentalJect Applicator Set FDA UDI
- Generic Name
- Cold/cool therapy spray FDA UDI
- Device Name
- DentalJect Applicator Set; Contains one DJ01000-00 DentalJect Applicator and one DJ02000-00 DentalJect Syringe Connector FDA UDI
- Model / Reference
- DJ04000-00 FDA UDI
- Description
- DentalJect Applicator Set; Contains one DJ01000-00 DentalJect Applicator and one DJ02000-00 DentalJect Syringe Connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010587379 FDA UDI
- 510(k) Number
- K243654 FDA UDI
- FDA Product Code
- MLY FDA UDI
- GMDN Term
- Cold/cool therapy spray FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cold/cool therapy spray
DentalJect Applicator Set by Vapocoolshot, Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243654 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 U | Pending data |
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Manufacturer
- Manufacturer
- Vapocoolshot, Inc
Sources (1)
- FDA UDI 5412c021-5544-4b08-a730-7506c07e55f3 34 fields · synced May 30, 2026