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
K182288Substantially Equivalent

TPH Spectra ST Flowable Composite Restorative

Dentsply Sirona Inc, York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182288 is the FDA 510(k) clearance record for TPH Spectra ST Flowable Composite Restorative, a class II device, cleared for Dentsply Sirona on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 86 510(k) clearances for Dentsply Sirona, from to . As of , FDA records show no recalls naming K182288.

Clearance record

Decision date
Received
(89 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Dentsply Sirona 221 W. Philadelphia St., York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBF

Trailing 12 months
19 clearances under product code EBF in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code EBF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20262
April 20265
May 20262
June 20262
July 20262
August 20261
September 20262
October 20260