Series Xe 140XE,40XE,10XE/SERIES Se 140SE,40SE,10SE/SERIES 10TE
FDA 510(k) K961494 · Micro-Mega Societe Anonyme
510(k) numberK961494
Submission
- Device name
- Series Xe 140XE,40XE,10XE/SERIES Se 140SE,40SE,10SE/SERIES 10TE
- Applicant
- Micro-Mega Societe Anonyme
Besancon, FR - Received
- April 18, 1996
- Decision date
- June 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional | Premium Plus (Dongguan) Limited | 09/15/2025SE |
| K240950 | Disposable Prophy AngleEGS · Abbreviated | Pacific Care Limited | 05/28/2025SE |
| K240183 | Star E900 Handpiece SeriesEGS · Traditional | Dentalez, Inc., Stardental Division | 09/19/2024SE |
| K230106 | General Cutting StraightEGS · Traditional | Nakanishi, Inc. | 05/24/2023SE |
| K222518 | FX ContraEGS · Traditional | Nakanishi, Inc. | 11/17/2022SE |
| K220874 | Smooth Drive contra angle and straight handpiecesEGS · Traditional | Lares Research | 11/07/2022SE |
| K220346 | Lotus Prophy AngleEGS · Traditional | Ajk Engineering, Inc. | 11/07/2022SE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional | Micro-Nx Co., Ltd. | 07/29/2022SE |
| K213139 | SURGmatic S15 L ProEGS · Traditional | Kavo Dental GmbH | 12/21/2021SE |
| K202960 | General Cutting Contra HandpieceEGS · Special | Nakanishi, Inc. | 10/27/2020SE |
More from Nakanishi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123276 | Mm-SealKIF · Traditional | 03/10/2014SE |
| K103123 | Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories)LQY · Traditional | 03/10/2011SE |
| K081268 | Sonic Air MM1500 + (Mid), Model 50400014ELC · Traditional | 08/10/2009SE |
| K042171 | Ax's Endo 04, 06, 08, 2.5, 40 , Models 50100206, 50100217, 50100218, 50100230, 50100232EGS · Traditional | 11/10/2004SE |
| K971350 | Series Xe, Series Se, Series TeEGS · Traditional | 06/04/1997SE |
| K961275 | Sirius 10, 10L, 40, 40LEFB · Traditional | 01/17/1997SE |
| K961235 | Sirius 180, 180L, 230, 230LEFB · Traditional | 01/08/1997SE |
| K961076 | MM 324EFB · Traditional | 04/26/1996SE |
| K950555 | J Single Use Head and JD Reusable HandleEGS · Traditional | 12/28/1995SE |
| K951272 | Relacs 7000ELC · Traditional | 05/12/1995SE |
Questions and answers
When was Series Xe 140XE,40XE,10XE/SERIES Se 140SE,40SE,10SE/SERIES 10TE cleared by the FDA?
Series Xe 140XE,40XE,10XE/SERIES Se 140SE,40SE,10SE/SERIES 10TE (K961494) received a 510(k) decision of Substantially Equivalent on June 26, 1996, 69 days after the submission was received.
What is the product code of K961494?
The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.