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
K161353Substantially Equivalent

ESTELITE BULK FILL Flow

Tokuyama Dental Corporation, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161353 is the FDA 510(k) clearance record for ESTELITE BULK FILL Flow, a class II device, cleared for Tokuyama Dental Corporation on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 19 510(k) clearances for Tokuyama Dental Corporation, from to . As of , FDA records show no recalls naming K161353.

Clearance record

Decision date
Received
(322 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Tokuyama Dental Corporation 38-9 Taitou 1-Chome, Taitou-Ku, Tokyo, JP
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