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LUNE™ PureHygiene EN0000-110-00

by Enamel Pure

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860013727000 UDI-DI Date14 Apr 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LUNE™ PureHygiene
Generic Name
Dental photo-activated disinfection system
Model / Reference
EN0000-110-00
Primary DI / UDI-DI
00860013727000
510(k) Number
FDA Product Code
GEX
GMDN Term
Dental photo-activated disinfection system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental photo-activated disinfection system

Other devices from Enamel Pure

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • 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
  • Expiration Date: No