510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K240183Substantially Equivalent

Star E900 Handpiece Series

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

K240183 is the FDA 510(k) clearance record for Star E900 Handpiece Series, a class I device, cleared for Dentalez, Inc., Stardental Division on under FDA product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental). FDA records list 2 510(k) clearances for Dentalez, Inc., Stardental Division, from to . As of , FDA records show no recalls naming K240183.

Clearance record

Decision date
Received
(240 days to decision)
Product code
EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Dentalez, Inc., Stardental Division 1816 Colonial Village Ln., Lancaster PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EGS

Trailing 12 months

FDA records hold no clearances under product code EGS in the trailing twelve months.

FDA records show no clearances under product code EGS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260