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EdgeEndo EO450421HTX

by Hsg-S Corp GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810213810552 UDI-DIDate19 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
EdgeEndo
Generic Name
Rotary/reciprocating endodontic file/rasp, single-use
Model / Reference
EO450421HTX
Primary DI / UDI-DI
00810213810552
FDA Product Code
EKS
GMDN Term
Rotary/reciprocating endodontic file/rasp, single-use
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

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Properties

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

Other properties (8)

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