510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243637Substantially Equivalent

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

Materialise N.V., Leuven, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243637 is the FDA 510(k) clearance record for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery, a class II device, cleared for Materialise NV on under FDA product code DZJ (Driver, Wire, And Bone Drill, Manual). FDA records list 61 510(k) clearances for Materialise NV, from to . As of , FDA records show no recalls naming K243637.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DZJ Driver, Wire, And Bone Drill, Manual
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Materialise NV Technologielaan 15, Leuven, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZJ

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