KMY · Class I · 21 CFR 872.5525

FDA Product Code KMY: Positioner, Tooth, Preformed

Leading manufacturers include American Orthodontics and Dentauraum, Inc..

12

Total

12

Cleared

229d

Avg days

1978

Since

FDA 510(k) Cleared Positioner, Tooth, Preformed Devices (Product Code KMY)

12 devices

1–12 of 12

Cleared Feb 13, 1995

DENT-O-CRYL ORTHODONTIC ACRYLIC

Dentauraum, Inc.

Cleared Nov 09, 1990

PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER

American Orthodontics

Cleared Mar 31, 1989

PREFORMED TEMPLATE FOR TOOTH POSITIONER

American Orthodontics

About Product Code KMY - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Apr 14, 1995

Product Code Info

Code	KMY
Device class	Class I
CFR	21 CFR 872.5525
Panel	Dental

Verify on FDA.gov

View KMY classification on FDA.gov →