TORQTECH

Handpiece, Contra- And Right-angle Attachment, Dental

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Torqtech.

Pre-market Notification Details

• Device ID: K103697
• 510k Number: K103697
• Device Name: TORQTECH
• Classification: Handpiece, Contra- And Right-angle Attachment, Dental
• Applicant: J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005
• Contact: Keith A Barritt
• Correspondent: Keith A Barritt; J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005
• Product Code: EGS
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-20
• Decision Date: 2012-01-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548213027408	K103697	000