510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971899Substantially Equivalent

Endo-Seal

Ultradent Products Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971899 is the FDA 510(k) clearance record for ENDO-SEAL, a class II device, cleared for Ultradent Products, Inc. on under FDA product code KIF (Resin, Root Canal Filling). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K971899.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Ultradent Products, Inc. 505 W. 10200 S., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code KIF

Trailing 12 months
7 clearances under product code KIF in the twelve months to November 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KIF, trailing twelve months
MonthClearances
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20262
October 20261
November 20260