510(k) · Cleared
ClearedPerioglas Bone Graft Particulate
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 14, 2006 as substantially equivalent to K040278 (Novabone Products, LLC, 2004) and 6 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1996. 13 later devices descend from it.
- Decided
- Feb 14, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K960978 (1996). 14 ancestors in all, the oldest K852682 (1985). 13 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 1 generation backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- This deviceK053387 Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
- Descendant · cites it directly · 4 of its ownK063596 Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC · 2007
- Descendant · 2 generations on · 3 of its ownK081432 Healos II Bone Graft SubstituteDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK063549 Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2007
- Descendant · 3 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · 2 generations on · 1 of its ownK091484 Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2009
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC · 2007 · cites it directly4descendants
- K081432Healos II Bone Graft SubstituteDepuy Spine, Inc. · 2008 · 2 generations on3descendants
- K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2007 · cites it directly2descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 3 generations on1descendant
- K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −1 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| 0 (this device) | K053387 | Perioglas Bone Graft Particulate | Novabone Products, LLC | 2006 | — |
| +1 | K063596 | Perioglas Putty-Bioactive Bone Graft Gel | Novabone Products, LLC | 2007 | — |
| +2 | K081432 | Healos II Bone Graft Substitute | Depuy Spine, Inc. | 2008 | — |
| +1 | K063549 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2007 | — |
| +3 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +2 | K091484 | Novabone Dental Putty - Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2009 | — |
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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K040278 | Perioglas-Bioglass Bone Graft SubstituteSummary page 1…d/or Augmentation 3. Legally Marketed Predicate Device: Predicate HI: PerioGlas - Synthetic Bone Graft Particulate [K040278, K992416, K962492, K930115] (Also named as NovaBone per Special 5 10(k) KOOO 149) Predicat… | 2004 |
| * | K992416 | Perioglas- Bioglass Bone Graft ParticulateSummary page 1…entation 3. Legally Marketed Predicate Device: Predicate HI: PerioGlas - Synthetic Bone Graft Particulate [K040278, K992416, K962492, K930115] (Also named as NovaBone per Special 5 10(k) KOOO 149) 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…Legally Marketed Predicate Device: Predicate HI: PerioGlas - Synthetic Bone Graft Particulate [K040278, K992416, K962492, K930115] (Also named as NovaBone per Special 5 10(k) KOOO 149) Predicate ¢2: NovaBone - R… | 1993 |
| * | K000149 | Novabone-Bioglass Bone Graft Particulate | 2000 |
| * | K052494 | Novabone-Bioactive Synthetic GraftSummary page 1…(Also named as NovaBone per Special 5 10(k) KOOO 149) Predicate ¢2: NovaBone - Resorbable Bone Graft Substitute [K052494, K021336] 4. Device Description PerioGlas is a one-component resorbable bone void filler composed of a synthetic… | 2005 |
| * | K021336 | Novabone-Resorbable Bone Graft SubstituteSummary page 1…(Also named as NovaBone per Special 5 10(k) KOOO 149) Predicate ¢2: NovaBone - Resorbable Bone Graft Substitute [K052494, K021336] 4. Device Description PerioGlas is a one-component resorbable bone void filler composed of a synthetic cal… | 2002 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063596 | Perioglas Putty-Bioactive Bone Graft Gel | 2007 | 4 |
| K063549 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | 2007 | 2 |
| K070055 | Bonalive Granules and Bonalive Plates | 2007 | 1 |
| K111105 | Curasan Osseolive Dental | 2012 | 0 |
| K112428 | Novabone Dental Morsels - Bioactive Synthetic Bone Graft | 2011 | 0 |
| K071937 | Bonalive Granules and Bonalive Plates | 2007 | 0 |
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 3.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K063596 (Novabone Products, LLC, 2007) has gone furthest, with 4 descendants of its own.
- 11 other devices also cite its predicate K040278.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PerioGlas 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/Infrabony defects * Ridge Augmentation…
Read the full statement (111 words)
The intended use of PerioGlas 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/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 PerioGlas® 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/K053387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053387: Perioglas Bone Graft Particulate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053387
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