Visalys Temp 13785

by Kettenbach GmbH & Co. KG

Visalys Temp 13785 (13786) is a Class II device made by Kettenbach GmbH & Co. KG, cleared under FDA 510(k) K122039 on 27 Dec 2012 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI E217137851), 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	NumberE217137851 UDI-DI	Date15 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK122039	Date27 Dec 2012Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K122039

Across registries

2 registries list this device

FDA 510(k) K122039 decided 27 Dec 2012 Active
FDA GUDID UDI-DI E217137851 listed 15 Sep 2016 Listed

Timeline

2 dated events

27 Dec 2012 Cleared FDA 510(k) K122039
15 Sep 2016 Listed FDA GUDID E217137851

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Visalys Temp
Generic name: Temporary dental crown/bridge
Model / Ref / Catalog: 13785, 13786

Primary DI / UDI-DI: E217137851
510(k) Number: K122039
FDA product code: EBG
GMDN term: Temporary dental crown/bridge

Device class: Class II
Regulation number: 872.3770
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Prescription use
Lot / batch number
Expiration date

Other properties (11, all answered No)