510(k) Report

FDA applicant

(Ems Sa) Electro Medical Systems

North Attleboro, MA5 decisions1999–20070 recalls

FDA records 5 decisions for (Ems Sa) Electro Medical Systems (North Attleboro, MA) from 1999 to 2007: 5 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EFB (Handpiece, Air-Powered, Dental). Its devices cite 8 predicates, 0 of them its own earlier devices. No 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 (Ems Sa) Electro Medical Systems’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

No recall linked to its devices since 2007.

FIG. 1 — (Ems Sa) Electro Medical Systems 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?

  • ELCScaler, Ultrasonic2decisions
  • EFBHandpiece, Air-Powered, Dental1decision
  • HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment1decision
  • EBZActivator, Ultraviolet, For Polymerization1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K073284Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 20074cite it
  • K992504Ems Kermit(Ems Sa) Electro Medical Systems · 20003cite it

What has FDA decided for it lately?

  • K073284Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 2007
  • K032099Swiss Master Light(Ems Sa) Electro Medical Systems · 2003
  • K992504Ems Kermit(Ems Sa) Electro Medical Systems · 2000
  • K991874Ems Surface Mount Scaler(Ems Sa) Electro Medical Systems · 1999
  • K991588Ems Swiss Orthoclast(Ems Sa) Electro Medical Systems · 1999

All 5 as (Ems Sa) Electro Medical Systems →