46-U1-2l-V

46-U1-2l-V is a Class II device made by Flexmedics, cleared under FDA 510(k) K973776 on 21 Nov 1997 and listed in FDA GUDID since 27 May 2020 (UDI-DI 10195291003339), active as of 23 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10195291003339 UDI-DI	Date27 May 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK973776	Date21 Nov 1997Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10195291003339
FDA 510(k) database 510(k) number K973776

Across registries

2 registries list this device

FDA 510(k) K973776 decided 21 Nov 1997 Active
FDA GUDID UDI-DI 10195291003339 listed 27 May 2020 Listed

Timeline

2 dated events

21 Nov 1997 Cleared FDA 510(k) K973776
27 May 2020 Listed FDA GUDID 10195291003339

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthodontic bracket, plastic, single-use
Model / reference: 46-U1-2L-V

Primary DI / UDI-DI: 10195291003339
510(k) Number: K973776
FDA product code: DYW
GMDN term: Orthodontic bracket, plastic, single-use

Device class: Class II
Regulation number: 872.5470
GUDID distribution status: In Commercial Distribution

Other devices from Flexmedics

See all devices from Flexmedics →

Properties

Single use
Prescription use
Lot / batch number
Manufacturing date

Other properties (11, all answered No)