510(k) · Cleared

Cleared

Orthoblast II DBM Demineralized Bone Matrix Paste and Putty

K060332510(k) TraditionalCleared Mar 29, 200648-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Isotis NV · NUN Bone Grafting Material, Human Source

Cleared on Mar 29, 2006 as substantially equivalent to K043573 (Isotis Orthobiologics, Inc., 2005) after a 48-day review. Its family tree reaches back 2 generations to 1996.

Decided: Mar 29, 2006
Review: 48 days
Class: Class II
Product code: NUN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K960267 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK960267 TBM SpongeBiocoll Laboratories, Inc. · 1996
1 generation backK043573 Dynagraft II DentalIsotis Orthobiologics, Inc. · 2005
This deviceK060332 Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis NV · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K960267	TBM Sponge	Biocoll Laboratories, Inc.	1996	—
−1	K043573	Dynagraft II Dental	Isotis Orthobiologics, Inc.	2005	—
0 (this device)	K060332	Orthoblast II DBM Demineralized Bone Matrix Paste and Putty	Isotis NV	2006	—

FIG. 1 — Lineage of K060332, 1996–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K043573	Dynagraft II Dental Summary page 1 …Bone Graft Material Regulatory Class: 11 Product Code: NUN 3. PREDICATE DEVICE DynaGraft 11Dental (Demineralized Bone Matrix) [K043573] 4. DEVICE DESCRIPTION OrthoBlasto II DBM Paste and Putty is derived from selected donated human bone tissue th…	Isotis Orthobiologics, Inc.	2005	—

Also cleared against K043573: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K043573.

How does its category compare?

All NUN devices

NUN Bone Grafting Material, Human Source: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUN

1in 2014

2007high 4 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUN

75in 2008

2007high 75 (2008)2026

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

2007high 25 (2013) · low 0 (2007)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	MAUDE reports
2007	1	—	0
2008	4	75	0
2009	1	—	1
2010	0	—	6
2011	1	—	13
2012	1	—	15
2013	0	—	25
2014	1	—	2
2015	0	—	6
2016	0	—	1
2017	0	—	10
2018	0	—	4
2019	0	—	10
2020	0	—	6
2021	0	—	6
2022	0	—	3
2023	0	—	0
2024	0	—	2
2025	0	—	6
2026	0	—	—

What is it indicated for?

OrthoBlast® II DBM Paste and Putty are bone filling materials 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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060332 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060332: Orthoblast II DBM Demineralized Bone Matrix Paste and Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060332

Report an extraction error

Are you the manufacturer?

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