DeviceClearance

Product code DYW— Dental

SPIRIT MB

Classification name
Bracket, Plastic, Orthodontic
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Total cleared
42
First cleared
Most recent

Market context for product code DYW

FDA has cleared 42 devices under product code DYW between 1978 and 2025, filed by 29 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 DYW

Recent clearances under product code DYW

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