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510(k) K251425

turbodent touch by Mectron S.P.A. — Product Code KOJ

K251425 is an FDA 510(k) premarket notification submitted by Mectron S.P.A. for the device "turbodent touch". The FDA issued a decision of Substantially Equivalent on May 9, 2025. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Mectron S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2025
Date Received
May 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type

Other clearances by Mectron S.P.A.

  • K242432 — MT-Bone (August 19, 2024)
  • K231391 — Combi Touch (May 15, 2023)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)
  • K153743 — PIEZOSURGERY PLUS (May 25, 2016)
  • K151248 — PIEZOSURGERY WHITE (September 4, 2015)
  • K151023 — COMPACT PIEZO LED (August 5, 2015)
  • K140965 — MULTIPIEZO PRO, MULTIPIEZO (August 20, 2014)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K122322 — PIEZOSURGERY TOUCH (December 6, 2012)

Other clearances for product code KOJ

  • K063236 — BETA-POWDER (February 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (November 23, 2004)
  • K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (January 15, 2004)
  • K033215 — PREPAIR (January 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (October 9, 2003)
  • K030292 — GROMAN PREPMASTER (April 15, 2003)
  • K021450 — CLINPRO PROPHY POWDER (August 1, 2002)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014252 — JETSTREAM (February 19, 2002)
  • K014249 — JETPOLISHER (February 19, 2002)

FDA data resources