Glenroe Elastibite Stimulator
FDA 510(k) K924351 · Glenroe Technologies
510(k) numberK924351
Submission
- Device name
- Glenroe Elastibite Stimulator
- Applicant
- Glenroe Technologies
Bradenton, FL, US - Received
- August 28, 1992
- Decision date
- January 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KMY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931615 | Nite-GuideKMY · Traditional | ORTHO-TAIN, Inc. | 04/14/1995SE |
| K942667 | Dent-O-Cryl Orthodontic AcrylicKMY · Traditional | Dentauraum, Inc. | 02/13/1995SE |
| 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 |
|---|---|---|
| K980053 | Glenroe ChainECI · Traditional | 02/24/1998SE |
| K945535 | Glenroe Ortho-SilEGD · Traditional | 01/27/1995SE |
| K932920 | Glenroe Plastic BracketDYW · Traditional | 08/24/1993SE |
| K931462 | Glenroe ChainECI · Traditional | 07/22/1993SE |
| K924140 | Tuff TiesECI · Traditional | 04/27/1993SE |
| K924139 | Glenroe Ortho SepsECI · Traditional | 04/08/1993SE |
| K924211 | EjectorDYN · Traditional | 03/31/1993SE |
| K924993 | Glenroe Band Seating Contouring InstrumentECS · Traditional | 11/25/1992SE |
Questions and answers
When was Glenroe Elastibite Stimulator cleared by the FDA?
Glenroe Elastibite Stimulator (K924351) received a 510(k) decision of Substantially Equivalent on January 6, 1994, 496 days after the submission was received.
What is the product code of K924351?
The FDA product code is KMY – Positioner, Tooth, Preformed, a Class I (low risk) device regulated under 21 CFR 872.5525.