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Varios U files 33mm ISO 35

by Nakanishi Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04560264562714 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Varios
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Model / Reference
U files 33mm ISO 35
Primary DI / UDI-DI
04560264562714
510(k) Number
FDA Product Code
ELC
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Device Class
Class II
Regulation Number
872.4850
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Cleared under the same submission (K113530)

Show all (12)

Other devices from Nakanishi Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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