Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2246821

FEI Number

2246821

Entity Name

MTI PRECISION PRODUCTS

City/State/Country

Coatesville, PA, US

Establishment Address

131 Birch St, Coatesville, PA 19320, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CNC Manufacturing, Inc. (Owner Number: 10048589)

Owner / Operator Contact Address

131 Birch St., Coatesville, PA 19320, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K073652

PMA Number

N/A

All Registered Proprietary Names

Lynx - High-Speed Handpiece Lynx - Low-Speed Handpiece TM5 5K Low-Speed Handpiece TM20 20K Low-Speed Handpiece Master Classic Low-Speed Motor Master Prophy Airlite- Low Speed Motor Lynx Contra Sheath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2015-01-29
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2015-01-29
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2018-07-05
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2016-05-04
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2016-05-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CNC Manufacturing, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

Similar Registrations

Registration Number	Establishment Name	Location
3017619674	FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.	Foshan Guangdong, CN
3014471275	TUNAP GMBH & CO. KG	Wolfratshausen Bavaria, DE
2133714	INTER-MED, INC.	Racine, WI, US
8010468	GEBR. BRASSELER GMBH & CO. KG	LEMGO North Rhine-Westphalia, DE
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2246821. Last updated year: 2026. Please use registration number 2246821 when referencing this establishment in official correspondence.