Manufacturer registered with FDA
CNC Manufacturing, Inc.
Coatesville, PA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 11
- 510(k) clearances
- 51989–2007
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Devices listed with FDA
What CNC Manufacturing, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Lynx - High-Speed HandpieceLynx - Low-Speed HandpieceLynx Contra SheathLynx High-Speed HandpieceLynx Low-Speed HandpieceMaster Classic Low-Speed MotorMaster Prophy Airlite- Low Speed MotorTM20 20K Low-Speed HandpieceTM5 5K Low-Speed Handpiece | 2015 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Lynx Contra Sheath | 2016 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Bur, Dental | 2016 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | — | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names CNC Manufacturing, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Feb 2007 | K070001 | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE | EFB Dental Air-Powered Handpiece |
| 28 Mar 1996 | K960541 | LYNX DPA DISPOSABLE PROPHY ANGLE | EFB Dental Air-Powered Handpiece |
| 29 Dec 1994 | K940261 | LYNX LOW-SPEED HANDPIECE | EFB Dental Air-Powered Handpiece |
| 15 May 1990 | K901488 | LYNX-SM, SCLAER DENTAL HANDPIECE | ELC Ultrasonic Scaler |
| 18 Dec 1989 | K895736 | LYNX-HIGH SPEED HANDPIECE | EFB Dental Air-Powered Handpiece |
Also lists devices cleared under other names
CNC Manufacturing, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nakamura Magnifier Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Mar 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | Nakamura Magnifier Co., Ltd. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MTI PRECISION PRODUCTSFDA reg. 2246821 | Coatesville, PA, United States | Manufacturer, Repacker / relabeler |
Other names on FDA records
Mti Precision Products
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048589). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.