510(k) · Cleared
ClearedPerioglas-Bioglass Bone Graft Substitute
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 1, 2004 as substantially equivalent to K992416 (Usbiomaterials Corp., 1999) and 3 other predicates after a 25-day review. Its family tree reaches back 2 generations to 1995. 80 later devices descend from it.
- Decided
- Mar 1, 2004
- Review
- 25 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K941780 (1995). 8 ancestors in all, the oldest K852682 (1985). 80 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 1 generation backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- This deviceK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · cites it directly · 38 of its ownK063422 BioaggregateInnovative Bioceramix, Inc. · 2006
- Descendant · 2 generations on · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · cites it directly · 18 of its ownK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- Descendant · cites it directly · 13 of its ownK053387 Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006
- Descendant · 2 generations on · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K063422BioaggregateInnovative Bioceramix, Inc. · 2006 · cites it directly38descendants
- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · 2 generations on37descendants
- K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005 · cites it directly18descendants
- K053387Perioglas Bone Graft ParticulateNovabone Products, LLC · 2006 · cites it directly13descendants
- K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −1 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| 0 (this device) | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +1 | K063422 | Bioaggregate | Innovative Bioceramix, Inc. | 2006 | — |
| +2 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +1 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| +1 | K053387 | Perioglas Bone Graft Particulate | Novabone Products, LLC | 2006 | — |
| +2 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K992416 | Perioglas- Bioglass Bone Graft ParticulateSummary page 1…. Legally Mariketed Predicate Device: Predicate: PenioGlas - Synthetic Bone Graft Particulate [K992416, K962492, K930115] (Also named as NovaBone per Special 5 10(k) KOOO1 49) 4. Device… | 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…riketed Predicate Device: Predicate: PenioGlas - Synthetic Bone Graft Particulate [K992416, K962492, K930115] (Also named as NovaBone per Special 5 10(k) KOOO1 49) 4. Device Description… | 1993 |
| * | K000149 | Novabone-Bioglass Bone Graft Particulate | 2000 |
What descends from it? (80)
See all 8012 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063422 | Bioaggregate | 2006 | 38 |
| K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | 2005 | 18 |
| K053387 | Perioglas Bone Graft Particulate | 2006 | 13 |
| K070998 | Inion Biorestore | 2007 | 4 |
| K063596 | Perioglas Putty-Bioactive Bone Graft Gel | 2007 | 4 |
| K063549 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | 2007 | 2 |
| K091484 | Novabone Dental Putty - Bioactive Synthetic Bone Graft | 2009 | 1 |
| K241186 | Synthetic Bone Graft Particulate | 2025 | 0 |
| K153230 | ShefaBone SCPC Resorbable Bone Graft | 2016 | 0 |
| K112428 | Novabone Dental Morsels - Bioactive Synthetic Bone Graft | 2011 | 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 9 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K063422 (Innovative Bioceramix, Inc., 2006) has gone furthest, with 38 descendants of its own.
- 9 other devices also cite its predicate K992416.
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 (112 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/K040278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040278: Perioglas-Bioglass Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040278
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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