510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992623Substantially Equivalent

Mitek Mini Anchor

Mitek Products, Westwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992623 is the FDA 510(k) clearance record for MITEK MINI ANCHOR, a class II device, cleared for Mitek Products on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 30 510(k) clearances for Mitek Products, from to . As of , FDA records show no recalls naming K992623.

Clearance record

Decision date
Received
(89 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Mitek Products 60 Glacier Dr., Westwood MA
510(k) summary
Summary
Third party review
No

Clearances, product code DZL

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