510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043573Substantially Equivalent

Dynagraft II Dental

IsoTis OrthoBiologics, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043573 is the FDA 510(k) clearance record for DYNAGRAFT II DENTAL, a class II device, cleared for Isotis Orthobiologics, 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 10 510(k) clearances for Isotis Orthobiologics, Inc., from to . As of , FDA records show no recalls naming K043573.

Clearance record

Decision date
Received
(214 days to decision)
Product code
NUN Bone Grafting Material, Human Source
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Isotis Orthobiologics, Inc. 2 Goodyear, Suite B, Irvine CA
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