510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K844471Substantially Equivalent

Visible Light-Cure Composite -Polishable

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844471 is the FDA 510(k) clearance record for VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE, a class I device, cleared for Dentsply Intl. on under FDA product code EBH (Material, Impression Tray, Resin). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K844471.

Clearance record

Decision date
Received
(81 days to decision)
Product code
EBH Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Applicant
Dentsply Intl. 570 W. College Ave., York PA
Third party review
No

Clearances, product code EBH

Trailing 12 months

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

FDA records show no clearances under product code EBH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EBH, 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