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Lo 260-200-501

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) K853788

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 Number00813110028167 UDI-DI Date1 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK853788 Date31 Oct 1985DecidedStatusActive

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  • Withdrawn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

Trade name
Lo
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
260-200-501
Primary DI / UDI-DI
00813110028167
510(k) Number
FDA product code
DZE
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K853788)

Show all (10)

Other devices from Bicon, LLC

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No