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Silent Nite 3D Sleep Appliance SN3D

by Prismatik Dentalcraft, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberD745SN3D0 UDI-DI Date7 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Silent Nite 3D Sleep Appliance
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis
Model / Ref / Catalog
SN3D
Primary DI / UDI-DI
D745SN3D0
FDA Product Code
LRK
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis
Device Class
Class II
Regulation Number
872.5570
GUDID distribution status
In Commercial Distribution

Other devices from Prismatik Dentalcraft, Inc.

See all devices from Prismatik Dentalcraft, Inc. →

Properties

  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No