Skip to content

Lo 260-250-503

by Bicon, LLC

Lo 260-250-503 is a Class II device made by Bicon, LLC, cleared under FDA 510(k) K853788 on 31 Oct 1985 and listed in FDA GUDID since 1 Sep 2019 (UDI-DI 00813110028136), active as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813110028136 UDI-DI Date1 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK853788 Date31 Oct 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K853788 decided 31 Oct 1985 Active
  • FDA GUDID UDI-DI 00813110028136 listed 1 Sep 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K853788
  2. Listed FDA GUDID 00813110028136

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  • Withdrawn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
260-250-503
Primary DI / UDI-DI
00813110028136
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

Similar devices in this category

Other devices filed under Dental implant suprastructure, permanent, preformed.

Other devices from Bicon, LLC

See all devices from Bicon, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)