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510(k) K133776

A-DEC/W&H ELECTRIC HANDPIECE MOTOR by A-Dec, Inc. — Product Code EBW

K133776 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "A-DEC/W&H ELECTRIC HANDPIECE MOTOR". The FDA issued a decision of Substantially Equivalent on May 28, 2014. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. A-Dec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2014
Date Received
December 12, 2013
Clearance Type
Special
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 A-Dec, Inc.

  • K213932 — A-dec 300, A-dec 500 (March 2, 2022)
  • K102234 — A-DEC 200 DENTAL SYSTEM (November 24, 2010)
  • K100647 — A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, (July 9, 2010)
  • K082716 — A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H A (January 15, 2009)
  • K082827 — A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT (January 7, 2009)
  • K082985 — A-DEC 334/335 DELIVERY SYSTEM (December 17, 2008)
  • K070663 — A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H S (July 5, 2007)
  • K051657 — A-DEC SELF-CONTAINED WATER SYSTEM (August 30, 2005)
  • K032757 — A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE (December 10, 2003)
  • K032756 — A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 (December 4, 2003)

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