MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE— 510(k) K070001

Clearance details

Applicant

Mti Precision Products

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

2007-01-03

Decision date

2007-02-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Lakewood, NJ, US

• K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)2026-01-12
• K251389 — High speed air turbine handpiece2026-01-12
• K242179 — Synea Fusion Handpieces (Intensiv & Profin)2025-02-28
• K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)2024-11-13
• K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)2024-11-12

• K960541 — LYNX DPA DISPOSABLE PROPHY ANGLE1996-03-28
• K940261 — LYNX LOW-SPEED HANDPIECE1994-12-29
• K901488 — LYNX-SM, SCLAER DENTAL HANDPIECE1990-05-15
• K895736 — LYNX-HIGH SPEED HANDPIECE1989-12-18

Injury

133

Malfunction

562

Total

695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →