766-800-00

766-800-00 is a Class I device made by Dentaurum, cleared under FDA 510(k) K935140 on 4 Feb 1994 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI J011766800000), 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	NumberJ011766800000 UDI-DI	Date15 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK935140	Date4 Feb 1994Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K935140

Across registries

2 registries list this device

FDA 510(k) K935140 decided 4 Feb 1994 Active
FDA GUDID UDI-DI J011766800000 listed 15 Sep 2016 Listed

Timeline

2 dated events

4 Feb 1994 Cleared FDA 510(k) K935140
15 Sep 2016 Listed FDA GUDID J011766800000

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthodontic archwire
Model / reference: 766-800-00

Primary DI / UDI-DI: J011766800000
510(k) Number: K935140
FDA product code: DZC
GMDN term: Orthodontic archwire

Device class: Class I
Regulation number: 872.5410
GUDID distribution status: In Commercial Distribution

Other devices from Dentaurum

See all devices from Dentaurum →

Properties

Single use
Prescription use
Lot / batch number

Other properties (12, all answered No)