510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070246Substantially Equivalent

Down Pak

Endo Twinn B.V., Amsterdam, NL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070246 is the FDA 510(k) clearance record for DOWN PAK, a class I device, cleared for Endo Twinn B.V. on under FDA product code EKM (Gutta-Percha). FDA records list 2 510(k) clearances for Endo Twinn B.V., from to . As of , FDA records show no recalls naming K070246.

Clearance record

Decision date
Received
(22 days to decision)
Product code
EKM Gutta-Percha
Regulation
21 CFR 872.3850
Device class
Class I
Review panel
Dental
Applicant
Endo Twinn B.V. Danzigerkade 17, Amsterdam, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKM

Trailing 12 months

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

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