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Kava Herbst Dual Laminate Lqz

by Apex Dental Sleep Lab

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 Number00860008847539 UDI-DI Date14 Apr 2026ListedStatusListed 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  • Withdrawn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
Kava Herbst Dual Laminate
Generic Name
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
Model / Reference
LQZ
Primary DI / UDI-DI
00860008847539
510(k) Number
FDA Product Code
LQZ
GMDN Term
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
Device Class
Class II
Regulation Number
872.5570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K182661)

Other devices from Apex Dental Sleep Lab

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

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
  • Expiration Date: No
  • Manufacturing Date: No