Positioner, Tooth, Preformed
A Preformed Tooth Positioner is a removable dental appliance used at the conclusion of orthodontic treatment to retain tooth positions, refine occlusion, and guide teeth into their final desired positions during the finishing phase of orthodontic care. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KMY and the applicable regulation is 21 CFR 872.5525 in the Dental specialty.
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Basic Information
- Product Code
- KMY
- Device Class
- FDA class 1
- Regulation Number
- 872.5525
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K931615 | NITE-GUIDE | Apr 14, 1995 | Substantially Equivalent | ORTHO-TAIN, Inc. |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Feb 13, 1995 | Substantially Equivalent | Dentauraum, Inc. |
| K924351 | GLENROE ELASTIBITE STIMULATOR | Jan 06, 1994 | Substantially Equivalent | Glenroe Technologies |
| K925064 | RELAX-O-GUARD | Sep 13, 1993 | Substantially Equivalent for Some Indications | Aquatemp Service Co., Inc. |
| K924975 | THE ORTHOTRAINER | Jul 08, 1993 | Substantially Equivalent | Myofunctional Research Corp. Pty. , Ltd. |
| K924974 | THE TMJ APPLIANCE | Jun 23, 1993 | Substantially Equivalent for Some Indications | Myofunctional Research Corp. Pty. , Ltd. |
| K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | Nov 09, 1990 | Substantially Equivalent | American Orthodontics |
| K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER | Mar 31, 1989 | Substantially Equivalent | American Orthodontics |
| K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jan 10, 1984 | Substantially Equivalent | Jeffrey H. Attlin |
| K831793 | AQUALIZER MOUTHPIECE | Aug 12, 1983 | Substantially Equivalent | Martin D. Lerman |
| K821458 | DYNAMIC FUNTIONAL POSITIONER | Jun 09, 1982 | Substantially Equivalent | Dynamic Functional Positioner, Inc. |
| K780619 | PREFORMED TOOTH POSITIONER | Jun 28, 1978 | Substantially Equivalent | Tp Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 112 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 112 registration numbers. Click on an entry to view related FDA registrations.