510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K873689Substantially Equivalent

Cranioplastic, Acrylic Cranioplasty Material

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873689 is the FDA 510(k) clearance record for CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL, a class II device, cleared for Dentsply Intl. on under FDA product code GXP (Methyl Methacrylate For Cranioplasty). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K873689.

Clearance record

Decision date
Received
(45 days to decision)
Product code
GXP Methyl Methacrylate For Cranioplasty
Regulation
21 CFR 882.5300
Device class
Class II
Review panel
Neurology
Applicant
Dentsply Intl. 570 W. College Ave., York PA
Third party review
No

Clearances, product code GXP

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