510(k) · Cleared
ClearedNovabone Dental Putty-Bioactive Synthetic Bone Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novabone Products, LLC · LYC Bone Grafting Material, Synthetic
Cleared on Mar 30, 2010 as substantially equivalent to K091484 (Novabone Products, LLC, 2009) and 1 other predicate after a 21-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Mar 30, 2010
- Review
- 21 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K960978 (1996). 26 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 6 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 5 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 4 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 3 generations backK053387 Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
- 2 generations backK063549 Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2007
- 1 generation backK091484 Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2009
- This deviceK100671 Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −6 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −5 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −4 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −3 | K053387 | Perioglas Bone Graft Particulate | Novabone Products, LLC | 2006 | — |
| −2 | K063549 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2007 | — |
| −1 | K091484 | Novabone Dental Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2009 | — |
| 0 (this device) | K100671 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 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 LYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K091484 | Novabone Dental Putty - Bioactive Synthetic Bone GraftSummary page 1…Synthetic 3. Legally Marketed Predicate Device: Predicate #1: NovaBone Dental Putty - Bioactive Synthetic Graft [K091484] Predicate #2: NovaBone Dental Putty - Bioactive Synthetic Graft [K063549]… | 2009 |
| * | K063549 | Novabone Dental Putty-Bioactive Synthetic Bone GraftSummary page 1…Graft [K091484] Predicate #2: NovaBone Dental Putty - Bioactive Synthetic Graft [K063549] 4. Device Description NovaBone Dental Putty is an osteoconductive, bioactive, bone void filler device. The device is… | 2007 |
| † | K882551 | Ambulatory PH Data Recorder System, Aph-2000 | 1988 |
| † | K832662 | Dental Syringe System-Various Styles | 1983 |
| † | K915147 | cartridge syringe applicator |
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 14 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 26 ancestors has a recall of any class.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Denmineralized Freeze Dried Bone) or may be mixed with either (typically 1: 1 ratio vlv) as a bone graft extender. Typical uses include: * Periodontal/Infrabony defects * Ridge…
Read the full statement (117 words)
The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Denmineralized Freeze Dried Bone) or may be mixed with either (typically 1: 1 ratio vlv) as a bone graft extender. Typical uses include:
* Periodontal/Infrabony defects
* Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
* Extraction sites (ridge maintenance/augmentation, implant preparation/placement)
* Sinus lifts
* Cystic cavities
* Cranio-facial augmentation
For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100671 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100671: Novabone Dental Putty-Bioactive Synthetic Bone Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100671
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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