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260-028-202

by Bicon, LLC

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K020137

FDA submission, from GUDID

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 Number00813110023438 UDI-DI Date1 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020137 Date4 Mar 2002DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dental power tool system handpiece, remotely-driven
Model / Ref / Catalog
260-028-202
Primary DI / UDI-DI
00813110023438
510(k) Number
FDA product code
EGS
GMDN term
Dental power tool system handpiece, remotely-driven
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental power tool system handpiece, remotely-driven

Other devices from Bicon, LLC

See all devices from Bicon, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (11)

  • Supplied 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