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DentalJect Starter Kit

FDA UDI

Class U (US FDA UDI)

by Vapocoolshot, Inc

Identity

Trade Name
DentalJect Starter Kit FDA UDI
Generic Name
Cold/cool therapy spray FDA UDI
Device Name
DentalJect Starter Kit; Contains one DJ03000-05 Box of 5 canisters, one DJ03000-01 canister, one DJ04000-00 DentalJect Applicator Set FDA UDI
Model / Reference
DJ05000-00 FDA UDI
Description
DentalJect Starter Kit; Contains one DJ03000-05 Box of 5 canisters, one DJ03000-01 canister, one DJ04000-00 DentalJect Applicator Set FDA UDI

Identifiers

Primary DI / UDI-DI
00860010587386 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cold/cool therapy spray

DentalJect Starter Kit by Vapocoolshot, Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cold/cool therapy spray.

Cleared under the same submission

K243654 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vapocoolshot, Inc

Sources (1)

  • FDA UDI 9dd6d1b4-84bc-402d-b1a9-bb632f57f38e 34 fields · synced Jun 8, 2026