Product code DYT— Dental

DENTAURUM SPACE MAINTAINER

Classification name: Maintainer, Space Preformed, Orthodontic
Device class: Class 1
Regulation: 21 CFR 872.5525
Advisory panel: Dental
Total cleared: 4
First cleared: 1978-06-30
Most recent: 1994-04-28

Market context for product code DYT

FDA has cleared 4 devices under product code DYT between 1978 and 1994, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19941 clearance
19871 clearance
19811 clearance
19781 clearance

Top applicants under product code DYT

Unitek Corp.1 clearance
Northwest Orthodontics, Inc.1 clearance
Dentec, Inc.1 clearance
Dentauraum, Inc.1 clearance

Recent clearances under product code DYT

K935856 — DENTAURUM SPACE MAINTAINERDentauraum, Inc.·1994-04-28
K864376 — FIBERBONDDentec, Inc.·1987-04-07
K812239 — UNITEK PALATAL BARUnitek Corp.·1981-09-21
K780814 — SAFETY STOP NECKSTRAPNorthwest Orthodontics, Inc.·1978-06-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.