510(k) · Cleared
Recalled · Class II · 2026Grafton Plus DBM Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteotech, Inc. · NUN Bone Grafting Material, Human Source
Cleared on Nov 30, 2005 as substantially equivalent to K960267 (Biocoll Laboratories, Inc., 1996) and 3 other predicates after a 426-day review. Its family tree reaches back 3 generations to 1985. It has been recalled 13 times.
- Decided
- Nov 30, 2005
- Review
- 426 days
- Class
- Class II
- Product code
- NUN
- Recalls
- 13
- Predicates
- 4
Its longest line of descent runs back 3 generations to K852682 (1985). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK852682 Calcitite Bone Graft Mat/Oral & Maxillofacial SurgCalcitek, Inc. · 1985
- 2 generations backK992416 Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1999
- 1 generation backK030682 Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc. · 2003
- This deviceK042707 Grafton Plus DBM PasteOsteotech, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852682 | Calcitite Bone Graft Mat/Oral & Maxillofacial Surg | Calcitek, Inc. | 1985 | — |
| −2 | K992416 | Perioglas- Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1999 | — |
| −1 | K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3 | Bioform, Inc. | 2003 | — |
| 0 (this device) | K042707 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 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? (5)
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 1…te devices. Trade/ProprietarV/Model Name Manufacturer 510(K) # TBM Sponge Biocoll Laboratories K960267 PerioGlass-BioGlass Bone NovaBone Products, Inc. K040278 Graft Particulate Calcium Hydr… | 1996 |
| * | K040278 | Perioglas-Bioglass Bone Graft SubstituteSummary page 1…510(K) # TBM Sponge Biocoll Laboratories K960267 PerioGlass-BioGlass Bone NovaBone Products, Inc. K040278 Graft Particulate Calcium Hydroxylapatite Implant BioForm, Inc. K030682 PerioGlass P… | 2004 |
| * | K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Summary page 1…ass-BioGlass Bone NovaBone Products, Inc. K040278 Graft Particulate Calcium Hydroxylapatite Implant BioForm, Inc. K030682 PerioGlass Plus-Settable Bone NovaBone Products, Inc. K031073 Graft Substitute In additio… | 2003 |
| * | K031073 | Perioglas Plus - Settable Bone Graft SubstituteSummary page 1…t Particulate Calcium Hydroxylapatite Implant BioForm, Inc. K030682 PerioGlass Plus-Settable Bone NovaBone Products, Inc. K031073 Graft Substitute In addition, GRAFTON PLUS® DBM Paste is substantially equivalent to human freeze drie… | 2003 |
| * | — | Human freeze dried bone, such as demineralized bone matrix Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2026 | Class II | Z-0137-2027 | Process change control | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product… |
| Apr 20, 2012 | Class II | Z-0084-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0087-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0088-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0091-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0092-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0093-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0083-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0089-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0090-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0085-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0086-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
| Apr 20, 2012 | Class II | Z-0094-2013 | Device Design | Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K960267.
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?
GRAFTON PLUS® DBM Paste is 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 created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement)…
Read the full statement (145 words)
GRAFTON PLUS® DBM Paste is 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 created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is absorbed/remodeled and replaced by host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042707: Grafton Plus DBM Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042707
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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