Data / Medical devices / United States / Mti Precision Products

Mti Precision Products: FDA-registered device maker in Coatesville, PA, United States, 4 510(k) clearances

Name: Mti Precision Products FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mti Precision Products is registered with the FDA (registration 2246821) in Coatesville, PA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 20, 2008. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2246821
Address: 131 Birch St, Coatesville, PA, United States, 19320
Owner or operator: CNC Manufacturing, Inc. (10048589)
Roles: Manufacturer, Repackager or relabeler
First device listed: January 29, 2015
Registered through: 2026
Brand names listed: Bur, Dental, Lynx - High-Speed Handpiece, Lynx - Low-Speed Handpiece, Lynx Contra Sheath, Lynx High-Speed Handpiece, Lynx Low-Speed Handpiece, Master Classic Low-Speed Motor, Master Prophy Airlite- Low Speed Motor and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Repackager or relabeler	accessdata.fda.gov
Bur, Dental	EJL	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 20, 2008	K073652	ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE	EFB	Substantially Equivalent	Nakamura Magnifier Co., Ltd.	accessdata.fda.gov
February 2, 2007	K070001	MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE	EFB	Substantially Equivalent	Mti Precision Products	accessdata.fda.gov
December 29, 1994	K940261	LYNX LOW-SPEED HANDPIECE	EFB	Substantially Equivalent	Mti Precision Products	accessdata.fda.gov
December 18, 1989	K895736	LYNX-HIGH SPEED HANDPIECE	EFB	Substantially Equivalent	Mti Precision Products	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 7, 2012	68570	Class II	Terminated	Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products	Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.	accessdata.fda.gov

Compare with other makers

Updated July 12, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.