510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KMYClass I

Positioner, Tooth, Preformed

21 CFR 872.5525 / Dental
FDA source (opens on fda.gov)

KMY is the FDA product code for Positioner, Tooth, Preformed, a class I device type, regulated under 21 CFR 872.5525. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KMY
Device name
Positioner, Tooth, Preformed
Regulation
21 CFR 872.5525
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code KMY

By decision year
12 clearances under product code KMY with a decision year between 1978 and 1995, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KMY by decision year
YearClearances
19781
19821
19831
19841
19891
19901
19933
19941
19952

Applicants with the most clearances

Product code KMY
Applicants holding the most 510(k) clearances under product code KMY
ApplicantClearances
American Orthodontics2
Myofunctional Research Corp. Pty. Ltd.2
Aquatemp Service Co., Inc.1
Dentauraum, Inc.1
Dynamic Functional Positioner, Inc.1
Glenroe Technologies1
Jeffrey H. Attlin1
Martin D. Lerman1
Ortho-Tain, Inc.1
Tp Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 106 companies shown, in name order