510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130235Substantially Equivalent

Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty

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

K130235 is the FDA 510(k) clearance record for SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY, a class II device, cleared for Hans Biomed Corp. 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 8 510(k) clearances for Hans Biomed Corp., from to . As of , FDA records show no recalls naming K130235.

Clearance record

Decision date
Received
(345 days to decision)
Product code
NUN Bone Grafting Material, Human Source
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Hans Biomed Corp. 5600 Wisconsin Ave., # 509, Chevy Chase MD
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