510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K120218Substantially Equivalent

Tek USA E-Generator Integrated LED Handpiece (High & Low Speed Air Turbnine Dental Handpiece)

Palm Beach Dental Supply D/B/A Tek USA, Pompano Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120218 is the FDA 510(k) clearance record for TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE), a class I device, cleared for Palm Beach Dental Supply D/B/A Tek USA on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list one 510(k) clearance for Palm Beach Dental Supply D/B/A Tek USA. As of , FDA records show no recalls naming K120218.

Clearance record

Decision date
Received
(156 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Palm Beach Dental Supply D/B/A Tek USA 2700 NE 24th St., Pompano Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EFB

Trailing 12 months
4 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 20261