510(k) · Cleared
ClearedDynagraft II Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis Orthobiologics, Inc. · NUN Bone Grafting Material, Human Source
Cleared on Jul 29, 2005 as substantially equivalent to K960267 (Biocoll Laboratories, Inc., 1996) after a 214-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.
- Decided
- Jul 29, 2005
- Review
- 214 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960267 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960267 TBM SpongeBiocoll Laboratories, Inc. · 1996
- This deviceK043573 Dynagraft II DentalIsotis Orthobiologics, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK060306 Accell Connexus Demineralized Bone Matrix PuttyIsotis NV · 2006
- Descendant · 2 generations on · 2 of its ownK080462 Progenix DBM PuttyMedtronic Sofamor Danek · 2008
- Descendant · 3 generations on · 1 of its ownK081950 Progenix PlusMedtronic Sofamor Danek, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK082463 ProgenixMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 0 of its ownK060332 Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis NV · 2006
Most influential descendants
Showing 5 of 5 · See all- K060306Accell Connexus Demineralized Bone Matrix PuttyIsotis NV · 2006 · cites it directly3descendants
- K080462Progenix DBM PuttyMedtronic Sofamor Danek · 2008 · 2 generations on2descendants
- K081950Progenix PlusMedtronic Sofamor Danek, Inc. · 2008 · 3 generations on1descendant
- K082463ProgenixMedtronic Sofamor Danek · 2008 · 3 generations on0descendants
- K060332Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis NV · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960267 | TBM Sponge | Biocoll Laboratories, Inc. | 1996 | — |
| 0 (this device) | K043573 | Dynagraft II Dental | Isotis Orthobiologics, Inc. | 2005 | — |
| +1 | K060306 | Accell Connexus Demineralized Bone Matrix Putty | Isotis NV | 2006 | — |
| +2 | K080462 | Progenix DBM Putty | Medtronic Sofamor Danek | 2008 | — |
| +3 | K081950 | Progenix Plus | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +3 | K082463 | Progenix | Medtronic Sofamor Danek | 2008 | — |
| +1 | K060332 | Orthoblast II DBM Demineralized Bone Matrix Paste and Putty | Isotis NV | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960267 | TBM SpongeSummary page 3…Common/Usual Name: Human Bone Graft Material Classification Name: Bone void filler (Unclassified) 3. PREDICATE DEVICES Tissue Bone Matrix Sponge (K960267), autograft. 4. DEVICE DESCRIPTION DynaGraft® II Dental is derived from selected donated human bone tissue that has… | 1996 |
| * | — | autograft Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NUN devicesNUN Bone Grafting Material, Human Source: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NUN
75in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUN
No recall names NUN since 2007.
Adverse event reports per year · NUN
6in 2025
MAUDE reports naming product code NUN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 75 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 25 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043573: Dynagraft II Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043573
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026