510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K981596Substantially Equivalent

Ultrapak E

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

K981596 is the FDA 510(k) clearance record for ULTRAPAK E, cleared for Ultradent Products, Inc. on under FDA product code MVL (Cord, Retraction). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K981596.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MVL Cord, Retraction
Device class
Unclassified
Review panel
Unknown
Applicant
Ultradent Products, Inc. 505 W. 10200 So., South Jordan UT
510(k) summary
Statement
Third party review
No

Clearances, product code MVL

Trailing 12 months
2 clearances under product code MVL in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MVL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260