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NuSmile NuCem NCRPKI

by Nusmile, Ltd

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 Number08809911118543 UDI-DI Date8 Apr 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  • Withdrawn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
NuSmile NuCem
Generic Name
Glass ionomer dental cement
Model / Reference
NCRPKI
Primary DI / UDI-DI
08809911118543
FDA Product Code
EMA
GMDN Term
Glass ionomer dental cement
Device Class
Class II
Regulation Number
872.3275
GUDID distribution status
In Commercial Distribution

Other devices from Nusmile, Ltd

See all devices from Nusmile, Ltd →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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