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MiniKut 1033525

by Dental Engineering Laboratories, LLC

MiniKut 1033525 is a Class I device made by Dental Engineering Laboratories, LLC, listed in FDA GUDID since 15 Aug 2022 (UDI-DI 00850001745307), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850001745307 UDI-DI Date15 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
MiniKut
Generic name
Rotary/reciprocating endodontic file/rasp, single-use
Model / reference
1033525
Primary DI / UDI-DI
00850001745307
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
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

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

Similar devices in this category

Other devices filed under Rotary/reciprocating endodontic file/rasp, single-use.

Other devices from Dental Engineering Laboratories, LLC

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)