510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K071912Substantially Equivalent

Apaceram Bone Graft Substitute

Pentax Corp., Chevy Chase MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071912 is the FDA 510(k) clearance record for APACERAM BONE GRAFT SUBSTITUTE, a class II device, cleared for Pentax Corp. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list one 510(k) clearance for Pentax Corp. As of , FDA records show no recalls naming K071912.

Clearance record

Decision date
Received
(110 days to decision)
Product code
MQV Filler, Bone Void, Calcium Compound
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Pentax Corp. 5600 Wisconsin Ave., Chevy Chase MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQV

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