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510(k) K961275

SIRIUS 10, 10L, 40, 40L by Micro-Mega Societe Anonyme — Product Code EFB

K961275 is an FDA 510(k) premarket notification submitted by Micro-Mega Societe Anonyme for the device "SIRIUS 10, 10L, 40, 40L". The FDA issued a decision of Substantially Equivalent on January 17, 1997. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Micro-Mega Societe Anonyme has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1997
Date Received
April 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Micro-Mega Societe Anonyme

  • K123276 — MM-SEAL (March 10, 2014)
  • K103123 — APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) (March 10, 2011)
  • K081268 — SONIC AIR MM1500 + (MID), MODEL 50400014 (August 10, 2009)
  • K042171 — AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 5 (November 10, 2004)
  • K971350 — SERIES XE, SERIES SE, SERIES TE (June 4, 1997)
  • K961235 — SIRIUS 180, 180L, 230, 230L (January 8, 1997)
  • K961494 — SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE (June 26, 1996)
  • K961076 — MM 324 (April 26, 1996)
  • K950555 — J SINGLE USE HEAD AND JD REUSABLE HANDLE (December 28, 1995)
  • K951272 — RELACS 7000 (May 12, 1995)

Other clearances for product code EFB

  • K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES (January 12, 2026)
  • K251389 — High speed air turbine handpiece (January 12, 2026)
  • K242179 — Synea Fusion Handpieces (Intensiv & Profin) (February 28, 2025)
  • K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, (November 13, 2024)
  • K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dent (November 12, 2024)
  • K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing Sys (September 20, 2024)
  • K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L, (April 30, 2024)
  • K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (April 25, 2024)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K232243 — EVO 700 series high speed handpiece (August 23, 2023)

FDA data resources