Torqtech

510(k) Number

K103697 ↗

FDA product code

EGS

FDA applicant

J. Morita USA, Inc.

Device class

Class I

Regulation

21 CFR Part 872.4200

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental).

• AX'S ENDO 04, 06, 08, 2.5, 40, MODELS 50100206, 50100217, 50100218, 50100230, 50100232 by Micro-Mega Societe Anonyme
• Titan 3 Low Speed Angle Attachments by DENTALEZ, INC.
• Q3 DISPOSABLE PROPHY ANGLE by Q3 Special Products, Inc.
• T1 Spray 5901665 by SIRONA Dental Systems GmbH
• ENDO 5994277 by SIRONA Dental Systems GmbH
• RITE-ANGLE DISPOSABLE PROPHY ANGLES by Ash-USA
• 23:1 REDUCTION ANGLE by Midwest Dental Products Corp.
• TORQTECH CA-10RC by J.MORITA MFG.CORP.
• TI-MAX Z45 by NAKANISHI INC.
• TORQTECH CA-4R-PP by J.MORITA MFG.CORP.

• Lubrina 2

  Class I

  FDA 510(k) K190509 Active Cleared 4 Mar 2020

• Veraview X800

  Class II

  FDA 510(k) K171012 Active Cleared 19 Dec 2017

• Root ZX3

  Class II

  FDA 510(k) K213477 Active Cleared 3 Aug 2022

• I-Dixel

  Class II

  FDA 510(k) K073704 Active Cleared 21 Feb 2008

See all devices from J. Morita U.S.A., Inc →