510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022032Substantially Equivalent

Acetal

Inovativ, LLC, Jefferson OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022032 is the FDA 510(k) clearance record for ACETAL, a class I device, cleared for Inovativ, LLC on under FDA product code EHP (Clasp, Preformed). FDA records list 3 510(k) clearances for Inovativ, LLC, from to . As of , FDA records show no recalls naming K022032.

Clearance record

Decision date
Received
(69 days to decision)
Product code
EHP Clasp, Preformed
Regulation
21 CFR 872.3285
Device class
Class I
Review panel
Dental
Applicant
Inovativ, LLC 1155 Twin Hills Dr., Jefferson OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EHP

Trailing 12 months

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

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