Dent-O-Cryl Orthodontic Acrylic
FDA 510(k) K942667 · Dentauraum, Inc.
510(k) numberK942667
Submission
- Device name
- Dent-O-Cryl Orthodontic Acrylic
- Applicant
- Dentauraum, Inc.
Newtown, PA, US - Received
- June 6, 1994
- Decision date
- February 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KMY
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|---|---|---|---|
| K931615 | Nite-GuideKMY · Traditional | ORTHO-TAIN, Inc. | 04/14/1995SE |
| 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 |
| K891328 | Preformed Template for Tooth PositionerKMY · Traditional | American Orthodontics | 03/31/1989SE |
| 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 |
More from Dynamic Functional Positioner, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952870 | Remanium: CS & G-SoftEJH · Traditional | 07/27/1995SE |
| K952867 | Remanium:Gm 700, GM 380, GM 800, GFHEJH · Traditional | 07/27/1995SE |
| K952866 | Rematitan TitaniumEJH · Traditional | 07/27/1995SE |
| K952865 | Remanium: 200,CS, 380, and CDEJH · Traditional | 07/26/1995SE |
| K952868 | Dentaurum Jacket Crown & Root PostsEBL · Traditional | 07/19/1995SE |
| K942666 | Orthalgenat Impression MaterialELW · Traditional | 08/10/1994SE |
| K936151 | Extraoral HeadgearDZB · Traditional | 08/01/1994SE |
| K942668 | O-Tray Impression TraysEHY · Traditional | 07/22/1994SE |
| K942665 | Orthocent: Liquid and PowderEMA · Traditional | 07/22/1994SE |
| K935856 | Dentaurum Space MaintainerDYT · Traditional | 04/28/1994SE |
Questions and answers
When was Dent-O-Cryl Orthodontic Acrylic cleared by the FDA?
Dent-O-Cryl Orthodontic Acrylic (K942667) received a 510(k) decision of Substantially Equivalent on February 13, 1995, 252 days after the submission was received.
What is the product code of K942667?
The FDA product code is KMY – Positioner, Tooth, Preformed, a Class I (low risk) device regulated under 21 CFR 872.5525.