DeviceClearance

Product code DZB— Dental

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Classification name
Headgear, Extraoral, Orthodontic
Device class
Class 2
Regulation
21 CFR 872.5500
Advisory panel
Dental
Total cleared
36
First cleared
Most recent

Market context for product code DZB

FDA has cleared 36 devices under product code DZB between 1977 and 2021, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DZB

Recent clearances under product code DZB

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