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Restoration 116

by Aceso Dental Laboratory Company Limited

Restoration 116 is a device classified as Not classified made by Aceso Dental Laboratory Company Limited, listed in FDA GUDID since 12 Oct 2022 (UDI-DI 08936214221165), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08936214221165 UDI-DI Date12 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Restoration
Generic name
Custom-made dental crown, metal/polymer
Model / reference
116
Primary DI / UDI-DI
08936214221165
FDA product code
NSN, NSP
GMDN term
Custom-made dental crown, metal/polymer
Device class
N
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental bridge, polymerCustom-made dental crown, ceramicDental bridge, ceramicDental veneer, professional

Other devices from Aceso Dental Laboratory Company Limited

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)