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EdgeEndo® EdgeFill™ for EdgeEndo® EE5020O

by Hsg-S Corp

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 Number00810213815212 UDI-DI Date18 Aug 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  • Withdrawn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
EdgeEndo® EdgeFill™ for EdgeEndo®
Generic Name
Warm-bonded endodontic obturation system obturator
Model / Reference
EE5020O
Primary DI / UDI-DI
00810213815212
FDA Product Code
EKM
GMDN Term
Warm-bonded endodontic obturation system obturator
Device Class
Class I
Regulation Number
872.3850
GUDID distribution status
In Commercial Distribution

Other devices from Hsg-S Corp

See all devices from Hsg-S Corp →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Manufacturing Date: No