510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K162661Substantially Equivalent

SavDenTM MTA Root Canal Filling Materials

Tyds Biotech Incorporation, Zhubei City, Hsinchu County, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162661 is the FDA 510(k) clearance record for SavDenTM MTA Root Canal Filling Materials, a class II device, cleared for Tyds Biotech Incorporation on under FDA product code KIF (Resin, Root Canal Filling). FDA records list one 510(k) clearance for Tyds Biotech Incorporation. As of , FDA records show no recalls naming K162661.

Clearance record

Decision date
Received
(211 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Tyds Biotech Incorporation Rm. 7, 2f., #229, Fuxing 2nd Rd., Zhubei City, Hsinchu County, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KIF

Trailing 12 months
6 clearances under product code KIF 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 KIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20262
October 20260