Locator® 260-300-503

Locator® 260-300-503 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 8 Mar 2016 (UDI-DI 00813110022400), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00813110022400 UDI-DI	Date8 Mar 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK853788	Date31 Oct 1985Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00813110022400
FDA 510(k) database 510(k) number K853788

Across registries

2 registries list this device

FDA 510(k) K853788 decided 31 Oct 1985 Active
FDA GUDID UDI-DI 00813110022400 listed 8 Mar 2016 Listed

Timeline

2 dated events

31 Oct 1985 Cleared FDA 510(k) K853788
8 Mar 2016 Listed FDA GUDID 00813110022400

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Locator®
Generic name: Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog: 260-300-503

Primary DI / UDI-DI: 00813110022400
510(k) Number: K853788
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

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)