Positioner, Tooth, Preformed
Regulation 872.5525
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KMY
| Company | 510(k)s | Recalls |
|---|---|---|
| American Orthodontics | 2 | 0 |
| Myofunctional Research Corp. Pty. , Ltd. | 2 | 0 |
| Aquatemp Service Co., Inc. | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Dynamic Functional Positioner, Inc. | 1 | 0 |
| Glenroe Technologies | 1 | 0 |
| Jeffrey H. Attlin | 1 | 0 |
| Martin D. Lerman | 1 | 0 |
| ORTHO-TAIN, Inc. | 1 | 0 |
| Tp Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 1995 | K931615 | NITE-GUIDE ORTHO-TAIN, Inc. | KMY |
| Feb 13, 1995 | K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC Dentauraum, Inc. | KMY |
| Jan 6, 1994 | K924351 | GLENROE ELASTIBITE STIMULATOR Glenroe Technologies | KMY |
| Sep 13, 1993 | K925064 | RELAX-O-GUARD Aquatemp Service Co., Inc. | KMY |
| Jul 8, 1993 | K924975 | THE ORTHOTRAINER Myofunctional Research Corp. Pty. , Ltd., AU | KMY |
| Jun 23, 1993 | K924974 | THE TMJ APPLIANCE Myofunctional Research Corp. Pty. , Ltd., AU | KMY |
| Nov 9, 1990 | K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER American Orthodontics | KMY |
| Mar 31, 1989 | K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER American Orthodontics | KMY |
| Jan 10, 1984 | K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE Jeffrey H. Attlin | KMY |
| Aug 12, 1983 | K831793 | AQUALIZER MOUTHPIECE Martin D. Lerman | KMY |
| Jun 9, 1982 | K821458 | DYNAMIC FUNTIONAL POSITIONER Dynamic Functional Positioner, Inc. | KMY |
| Jun 28, 1978 | K780619 | PREFORMED TOOTH POSITIONER Tp Laboratories, Inc. | KMY |
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