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DentalJect Applicator DJ01000-00

by Vapocoolshot, Inc

DentalJect Applicator DJ01000-00 is a cold/cool therapy spray (FDA unclassified; FDA product code MLY, Vapocoolant Device) made by Vapocoolshot, Inc, cleared under FDA 510(k) K243654 on 30 May 2025 and listed in FDA GUDID since 7 Nov 2025 (UDI-DI 00860010587355), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K243654

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860010587355 UDI-DI Date7 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243654 Date30 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243654 decided 30 May 2025 Active
  • FDA GUDID UDI-DI 00860010587355 listed 7 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243654
  2. Listed FDA GUDID 00860010587355

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DentalJect Applicator
Generic name
Cold/cool therapy spray
Model / Ref / Catalog
DJ01000-00
Primary DI / UDI-DI
00860010587355
510(k) Number
FDA product code
MLY
GMDN term
Cold/cool therapy spray
Device class
U
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243654)

and 3 more cleared under K243654

Similar devices

Other devices filed under FDA product code MLY (Vapocoolant Device).

Other devices from Vapocoolshot, Inc

See all devices from Vapocoolshot, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)