MM 324
FDA 510(k) K961076 · Micro-Mega Societe Anonyme
510(k) numberK961076
Submission
- Device name
- MM 324
- Applicant
- Micro-Mega Societe Anonyme
Besancon, FR - Received
- March 18, 1996
- Decision date
- April 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251389 | High speed air turbine handpieceEFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional | W&H Dentalwerk Bürmoos GmbH | 02/28/2025SE |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 11/13/2024SE |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional | Nakanishi, Inc. | 09/20/2024SE |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional | Litu Tech , Ltd. | 04/30/2024SE |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | Nakanishi, Inc. | 04/25/2024SE |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
| K232243 | EVO 700 series high speed handpieceEFB · Special | Ttbio Corp. | 08/23/2023SE |
More from Ttbio Corp.
| 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 |
| K961494 | Series Xe 140XE,40XE,10XE/SERIES Se 140SE,40SE,10SE/SERIES 10TEEGS · Traditional | 06/26/1996SE |
| 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 MM 324 cleared by the FDA?
MM 324 (K961076) received a 510(k) decision of Substantially Equivalent on April 26, 1996, 39 days after the submission was received.
What is the product code of K961076?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.