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Kennametal Stellite Stellite N9

by Kennametal Stellite (Shanghai) Co., 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06972796430023 UDI-DI Date16 Dec 2019ListedStatusListed 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  • Withdrawn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
Kennametal Stellite
Generic Name
Dental casting non-noble alloy
Model / Ref / Catalog
Stellite N9
Description
Nickel-Chromium Ceramic Dental Alloy ISO 22674 Type 3 Ni62.0Cr23.0Mo11.0Fe1.5Si2.2C
Primary DI / UDI-DI
06972796430023
FDA Product Code
EJH
GMDN Term
Dental casting non-noble alloy
Device Class
Class II
Regulation Number
872.3710
GUDID distribution status
In Commercial Distribution
Size
Length — 12.5 Millimeter
Outer Diameter — 8.0 Millimeter

Other devices from Kennametal Stellite (Shanghai) Co., Ltd.

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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