MM 324— 510(k) K961076

Clearance details

Applicant

Micro-Mega Societe Anonyme

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

1996-03-18

Decision date

1996-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Besancon, FR

• K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)2026-01-12
• K251389 — High speed air turbine handpiece2026-01-12
• K242179 — Synea Fusion Handpieces (Intensiv & Profin)2025-02-28
• K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)2024-11-13
• K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)2024-11-12

• K123276 — MM-SEAL2014-03-10
• K103123 — APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)2011-03-10
• K081268 — SONIC AIR MM1500 + (MID), MODEL 504000142009-08-10
• K042171 — AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 501002322004-11-10
• K971350 — SERIES XE, SERIES SE, SERIES TE1997-06-04

Injury

133

Malfunction

562

Total

695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →