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 Feb 12, 2007 as substantially equivalent to K053387 (Novabone Products, LLC, 2006) and 7 other predicates after an 80-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.
- Decided
- Feb 12, 2007
- Review
- 80 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K960978 (1996). 20 ancestors in all, the oldest K852682 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 2 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 1 generation backK053387 Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
- This deviceK063549 Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2007
- Descendant · cites it directly · 1 of its ownK091484 Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2009
- Descendant · cites it directly · 0 of its ownK100671 Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −2 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −1 | K053387 | Perioglas Bone Graft Particulate | Novabone Products, LLC | 2006 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 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? (8)
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 |
|---|---|---|---|
| * | K053387 | Perioglas Bone Graft ParticulateSummary page 1…nd/or Augmentation 3. Legally Marketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K053387, K040278, K992416, K962492, K930115] (Also named as NovaBone per Special 510(k) K1000149)… | 2006 |
| * | K040278 | Perioglas-Bioglass Bone Graft SubstituteSummary page 1…mentation 3. Legally Marketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K053387, K040278, K992416, K962492, K930115] (Also named as NovaBone per Special 510(k) K1000149) Predicate… | 2004 |
| * | K992416 | Perioglas- Bioglass Bone Graft ParticulateSummary page 1…3. Legally Marketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K053387, K040278, K992416, K962492, K930115] (Also named as NovaBone per Special 510(k) K1000149) Predicate #2:… | 1999 |
| * | K962494 | Perioglas - Bioglass Bone Graft Particulate Our reading of the summary gave K962492, FDA’s number for Silenzio Plus Continuous Positive Airway Pressure System (Nidek Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PerioGlas - Synthetic Bone Graft Particulate”. | 1996 |
| * | K930115 | PerioglassSummary page 1…arketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K053387, K040278, K992416, K962492, K930115] (Also named as NovaBone per Special 510(k) K1000149) Predicate #2: NovaBone Putt… | 1993 |
| * | K060728 | Novabone Putty - Bioactive Synthetic GraftSummary page 1…(Also named as NovaBone per Special 510(k) K1000149) Predicate #2: NovaBone Putty II - Bioactive Synthetic Graft [K060728] Predicate #3: Exactech Resorbable Bone Paste - [K020078] Predicate #4: Grafton DBM - [K051195]… | 2006 |
| * | K020078 | Exactech Resorbable Bone PasteSummary page 1…cate #2: NovaBone Putty II - Bioactive Synthetic Graft [K060728] Predicate #3: Exactech Resorbable Bone Paste - [K020078] Predicate #4: Grafton DBM - [K051195] 4. Device Description NovaBone Dental Putty is an osteocondu… | 2004 |
| * | K051195 | Grafton DBMSummary page 1…ic Graft [K060728] Predicate #3: Exactech Resorbable Bone Paste - [K020078] Predicate #4: Grafton DBM - [K051195] 4. Device Description NovaBone Dental Putty is an osteoconductive, bioactive, bone void filler device. The… | 2005 |
What descends from it? (2)
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K091484 (Novabone Products, LLC, 2009) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K053387.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include: * Periodontal/lnfrabony 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 (Demineralized Freeze Dried Bone) or may be mixed
with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:
* Periodontal/lnfrabony 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/K063549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063549: Novabone Dental Putty-Bioactive Synthetic Bone Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063549
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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