607-152-00

607-152-00 is a Class I device made by Dentaurum, listed in FDA GUDID since 18 Sep 2019 (UDI-DI J011607152000), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

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	NumberJ011607152000 UDI-DI	Date18 Sep 2019Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name: Orthodontic palate expander/teeth aligner, bonded
Model / reference: 607-152-00

Primary DI / UDI-DI: J011607152000
FDA product code: DYJ
GMDN term: Orthodontic palate expander/teeth aligner, bonded

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

Similar devices

Other devices filed under FDA product code DYJ (RETAINER, SCREW EXPANSION, ORTHODONTIC).

Other devices from Dentaurum

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Properties

Single use
Prescription use
Premarket exempt
Lot / batch number

Other properties (11, all answered No)