510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K080418Substantially Equivalent

Regenafil, Regenaform, Alriva Dbm Paste, Sltiva Dm with Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Alachua FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080418 is the FDA 510(k) clearance record for REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST, a class II device, cleared for Regeneration Technologies, Inc. on under FDA product code NUN (Bone Grafting Material, Human Source). FDA's definition for product code NUN reads: "INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE...". FDA records list 100 510(k) clearances for RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), from to . As of , FDA records show no recalls naming K080418.

Clearance record

Decision date
Received
(75 days to decision)
Product code
NUN Bone Grafting Material, Human Source
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Regeneration Technologies, Inc. 11621 Research Cir., Alachua FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUN

Trailing 12 months

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

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