Mti Precision Products
Coatesville, PA, US
MTI PRECISION PRODUCTS appears in FDA device records in Coatesville, PA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Mti Precision Products between 1989 and 2007. The busiest year on record is 1989, with 1. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070001 | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE | EFB | Substantially Equivalent | |
| K960541 | LYNX DPA DISPOSABLE PROPHY ANGLE | EFB | Substantially Equivalent | |
| K940261 | LYNX LOW-SPEED HANDPIECE | EFB | Substantially Equivalent | |
| K901488 | LYNX-SM, SCLAER DENTAL HANDPIECE | ELC | Substantially Equivalent | |
| K895736 | LYNX-HIGH SPEED HANDPIECE | EFB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2246821 | 2246821 | MTI PRECISION PRODUCTS | 131 Birch St, Coatesville, PA 19320 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2044-2014 | Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products | Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
