510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K130455Substantially Equivalent

430 Swl 45 and 430 Sw 45 High-Speed Handpieces

Dentalez Group, Stardental Division, Lancaster PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130455 is the FDA 510(k) clearance record for 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES, a class I device, cleared for Dentalez Group, Stardental Division on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 2 510(k) clearances for Dentalez Group, Stardental Division, from to . As of , FDA records show no recalls naming K130455.

Clearance record

Decision date
Received
(215 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Dentalez Group, Stardental Division 1816 Colonial Village Ln., Lancaster PA
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