510(k) Report

FDA applicant

Mti Precision Products

Lakewood, NJ5 decisions1989–20071 recall

FDA records 5 decisions for Mti Precision Products (Lakewood, NJ) from 1989 to 2007: 5 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and ELC (Scaler, Ultrasonic). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Mti Precision Products’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mti Precision Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EFBHandpiece, Air-Powered, Dental4decisions
  • ELCScaler, Ultrasonic1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K940261Lynx Low-Speed HandpieceMti Precision Products · 19941cites it
  • K901488Lynx-SM, Sclaer Dental HandpieceMti Precision Products · 19901cites it

What has FDA decided for it lately?

  • K070001Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed Handpiece and TM20 Low Speed…Mti Precision Products · 2007
  • K960541Lynx Dpa Disposable Prophy AngleMti Precision Products · 1996
  • K940261Lynx Low-Speed HandpieceMti Precision Products · 19941 recall
  • K901488Lynx-SM, Sclaer Dental HandpieceMti Precision Products · 1990
  • K895736Lynx-High Speed HandpieceMti Precision Products · 1989

All 5 as Mti Precision Products →

What has been recalled?

1 recall linked to its devices; the latest:

  • K940261Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental ProductsMay 7, 2012Class II