160-100-02

160-100-02 is a Class I device made by Dentaurum, cleared under FDA 510(k) K942667 on 13 Feb 1995 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI J011160100020), 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	NumberJ011160100020 UDI-DI	Date15 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK942667	Date13 Feb 1995Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K942667

Across registries

2 registries list this device

FDA 510(k) K942667 decided 13 Feb 1995 Active
FDA GUDID UDI-DI J011160100020 listed 15 Sep 2016 Listed

Timeline

2 dated events

13 Feb 1995 Cleared FDA 510(k) K942667
15 Sep 2016 Listed FDA GUDID J011160100020

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthodontic palate expander/teeth aligner, self-removable
Model / reference: 160-100-02

Primary DI / UDI-DI: J011160100020
510(k) Number: K942667
FDA product code: KMY
GMDN term: Orthodontic palate expander/teeth aligner, self-removable

Device class: Class I
Regulation number: 872.5525
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)