# K043573: Dynagraft II Dental

- Pathway: 510(k) (Traditional)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Jul 29, 2005 after 214 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960267 (1996). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960267: TBM Sponge, Biocoll Laboratories, Inc. (1996) Summary page 3.
- (no number) autograft: named in the summary without a submission number

## Most influential descendants
- K060306: Accell Connexus Demineralized Bone Matrix Putty (2006), 3 descendants of its own
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K081950: Progenix Plus (2008), 1 descendant of its own
- K082463: Progenix (2008), 0 descendants of its own
- K060332: Orthoblast II DBM Demineralized Bone Matrix  Paste and Putty (2006), 0 descendants of its own

## Indications for use
DynaGraft I1Dental is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes: - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of maxillary sinus floor - Treatment of periodontal defects

Source page: https://510kreport.com/device/K043573
Methodology: https://510kreport.com/methodology