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System 18™ Partial Denture Alloy

by Dentsply International

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD001N0016350 UDI-DI Date31 Jan 2017ListedStatusListed GUDID: not 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  • Withdrawn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
System 18™
Generic Name
Dental casting non-noble alloy
Model / Ref / Catalog
Partial Denture Alloy, N001635
Primary DI / UDI-DI
D001N0016350
FDA Product Code
EJH
GMDN Term
Dental casting non-noble alloy
Device Class
Class II
Regulation Number
872.3710
GUDID distribution status
Not in Commercial Distribution
Size
Weight — 1 Kilogram

Other devices from Dentsply International

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Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

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