Orthosource 557-846

by Ortho Source

Orthosource 557-846 is a Class II device made by Ortho Source, cleared under FDA 510(k) K860959 on 25 Mar 1986 and listed in FDA GUDID since 17 Dec 2019 (UDI-DI D9115578460), 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	NumberD9115578460 UDI-DI	Date17 Dec 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK860959	Date25 Mar 1986Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K860959

Across registries

2 registries list this device

FDA 510(k) K860959 decided 25 Mar 1986 Active
FDA GUDID UDI-DI D9115578460 listed 17 Dec 2019 Listed

Timeline

2 dated events

25 Mar 1986 Cleared FDA 510(k) K860959
17 Dec 2019 Listed FDA GUDID D9115578460

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Orthosource
Generic name: Orthodontic bracket adhesive
Model / reference: 557-846

Primary DI / UDI-DI: D9115578460
510(k) Number: K860959
FDA product code: DYH
GMDN term: Orthodontic bracket adhesive

Device class: Class II
Regulation number: 872.3750
GUDID distribution status: In Commercial Distribution

Other devices from Ortho Source

See all devices from Ortho Source →

Properties

Lot / batch number
Expiration date

Other properties (13, all answered No)