Preformed Template for Tooth Positioner
FDA 510(k) K891328 · American Orthodontics
510(k) numberK891328
Submission
- Device name
- Preformed Template for Tooth Positioner
- Applicant
- American Orthodontics
Sheboygan, WI, US - Received
- March 10, 1989
- Decision date
- March 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K931615 | Nite-GuideKMY · Traditional | ORTHO-TAIN, Inc. | 04/14/1995SE |
| K942667 | Dent-O-Cryl Orthodontic AcrylicKMY · Traditional | Dentauraum, Inc. | 02/13/1995SE |
| K924351 | Glenroe Elastibite StimulatorKMY · Traditional | Glenroe Technologies | 01/06/1994SE |
| K925064 | Relax-O-GuardKMY · Traditional | Aquatemp Service Co., Inc. | 09/13/1993SN |
| K924975 | The OrthotrainerKMY · Traditional | Myofunctional Research Corp. Pty. , Ltd. | 07/08/1993SE |
| K924974 | The TMJ ApplianceKMY · Traditional | Myofunctional Research Corp. Pty. , Ltd. | 06/23/1993SN |
| K904128 | Performed Template W/Fragrance for Tooth PostionerKMY · Traditional | American Orthodontics | 11/09/1990SE |
| K833455 | Remoldable Craniomandibular ApplianceKMY · Traditional | Jeffrey H. Attlin | 01/10/1984SE |
| K831793 | Aqualizer MouthpieceKMY · Traditional | Martin D. Lerman | 08/12/1983SE |
| K821458 | Dynamic Funtional PositionerKMY · Traditional | Dynamic Functional Positioner, Inc. | 06/09/1982SE |
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Questions and answers
When was Preformed Template for Tooth Positioner cleared by the FDA?
Preformed Template for Tooth Positioner (K891328) received a 510(k) decision of Substantially Equivalent on March 31, 1989, 21 days after the submission was received.
What is the product code of K891328?
The FDA product code is KMY – Positioner, Tooth, Preformed, a Class I (low risk) device regulated under 21 CFR 872.5525.