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Endodontic Hand Instruments 06321006R

by Roydent Dental Products Inc 2 variants

Endodontic Hand Instruments 06321006R (07321040R) is a Class I device made by Roydent Dental Products Inc, listed in FDA GUDID since 9 Nov 2022 (UDI-DI D80907321040R1), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD80907321040R1 UDI-DI Date9 Nov 2022ListedStatusListed 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  • Withdrawn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
Endodontic Hand Instruments
Generic name
Rotary/reciprocating endodontic file/rasp, single-use
Model / Ref / Catalog
06321006R, 07321040R
Primary DI / UDI-DI
D80907321040R1
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

Related devices

Category: Rotary/reciprocating endodontic file/rasp, single-use

Other devices from Roydent Dental Products Inc

See all devices from Roydent Dental Products Inc →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)