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510(k) K132570

ELECTRIC HANDPIECE SYSTEM by Ttbio Corp. — Product Code EBW

K132570 is an FDA 510(k) premarket notification submitted by Ttbio Corp. for the device "ELECTRIC HANDPIECE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 2014. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Ttbio Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2014
Date Received
August 15, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Ttbio Corp.

  • K232243 — EVO 700 series high speed handpiece (August 23, 2023)
  • K210832 — EVOCLEAN CLEANsert Ultrasonic Insert (February 2, 2022)
  • K201317 — TTBIO EVOCLEAN Ultrasonic Scaler (December 4, 2020)
  • K190508 — EVO 450 series High Speed Handpieces (December 11, 2019)
  • K141183 — EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIE (February 27, 2015)

Other clearances for product code EBW

  • K251407 — Motor Handpiece and Control Unit (SDI10) (January 30, 2026)
  • K251701 — Star E900 Electric System (January 12, 2026)
  • K251811 — Motor and Apex Module (MaAM) (August 25, 2025)
  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)

FDA data resources