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Gemini Nova Intraoral PBM Adapter Kit 3mm 6364

by Azena Medical, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850010501468 UDI-DI Date15 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Gemini Nova Intraoral PBM Adapter Kit 3mm
Generic Name
Dental diode laser system
Model / Ref / Catalog
6364, RJ-005-1019
Primary DI / UDI-DI
00850010501468
510(k) Number
FDA Product Code
ILY, NVK, GEX
GMDN Term
Dental diode laser system
Device Class
Class II
Regulation Number
890.5500, 878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K260765)

Show all (12)

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No