510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132478Substantially Equivalent

Air-Flow Handy 3.0

E.M.S. - Electro Medical Systems SA, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132478 is the FDA 510(k) clearance record for AIR-FLOW HANDY 3.0, a class I device, cleared for E.M.S Electro Medical Systems S.A on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 41 510(k) clearances for E.M.S Electro Medical Systems S.A, from to . As of , FDA records show no recalls naming K132478.

Clearance record

Decision date
Received
(246 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
E.M.S Electro Medical Systems S.A 62 Forest St., Suite 300, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EFB

Trailing 12 months
3 clearances under product code EFB in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260