KMY · Class I · 21 CFR 872.5525

FDA Product Code KMY: Positioner, Tooth, Preformed

Leading manufacturers include American Orthodontics, Myofunctional Research Corp. Pty. , Ltd. and Tp Laboratories, 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 Apr 14, 1995
NITE-GUIDE
K931615
Ortho-Tain, Inc.
Dental · 743d
Cleared Feb 13, 1995
DENT-O-CRYL ORTHODONTIC ACRYLIC
K942667
Dentauraum, Inc.
Dental · 252d
Cleared Jan 06, 1994
GLENROE ELASTIBITE STIMULATOR
K924351
Glenroe Technologies
Dental · 496d
Cleared Sep 13, 1993
RELAX-O-GUARD
K925064
Aquatemp Service Co., Inc.
Dental · 342d
Cleared Jul 08, 1993
THE ORTHOTRAINER
K924975
Myofunctional Research Corp. Pty. , Ltd.
Dental · 281d
Cleared Jun 23, 1993
THE TMJ APPLIANCE
K924974
Myofunctional Research Corp. Pty. , Ltd.
Dental · 266d
Cleared Nov 09, 1990
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
K904128
American Orthodontics
Dental · 65d
Cleared Mar 31, 1989
PREFORMED TEMPLATE FOR TOOTH POSITIONER
K891328
American Orthodontics
Dental · 21d
Cleared Jan 10, 1984
REMOLDABLE CRANIOMANDIBULAR APPLIANCE
K833455
Jeffrey H. Attlin
Dental · 105d
Cleared Aug 12, 1983
AQUALIZER MOUTHPIECE
K831793
Martin D. Lerman
Dental · 70d
Cleared Jun 09, 1982
DYNAMIC FUNTIONAL POSITIONER
K821458
Dynamic Functional Positioner, Inc.
Dental · 33d
Cleared Jun 28, 1978
PREFORMED TOOTH POSITIONER
K780619
Tp Laboratories, Inc.
Dental · 76d

About Product Code KMY - Regulatory Context