510(k) · Cleared
ClearedPerioglas - Bioglass Bone Graft Particulate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usbiomaterials Corp. · LYC Bone Grafting Material, Synthetic
Cleared on Sep 20, 1996 as substantially equivalent to K952922 (Orthovita Co., 1995) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1995. 158 later devices descend from it.
- Decided
- Sep 20, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941780 (1995). 2 ancestors in all. 158 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK941780 Orthovita BiogranOrthovita Co. · 1995
- This deviceK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- Descendant · cites it directly · 85 of its ownK033994 Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · 2 generations on · 84 of its ownK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · cites it directly · 80 of its ownK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- Descendant · 3 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
- Descendant · 4 generations on · 47 of its ownK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 158 · See all- K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · cites it directly85descendants
- K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004 · 2 generations on84descendants
- K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004 · cites it directly80descendants
- K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008 · 3 generations on59descendants
- K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010 · 4 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| 0 (this device) | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| +1 | K033994 | Novabone-BBG-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +2 | K041613 | Novabone - AR - Resorbable Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +1 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| +3 | K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2008 | — |
| +4 | K101860 | Novabone Putty- Bioactive Synthetic Bone Graft | Novabone Products, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K952922 | Biogran Bioactive Glass Synthetic Bone Graft MaterialSummary page 1…nd ridge augmentation based upon additional clinical data and determination of substantial equivalence to the legally marketed device Orthovita- Biogran™ (Ref. [510(k)]# K952922, K941780). To confirm safety and efficacy, a recently completed human clinical study in extraction sites demonstrated favorable… | 1995 |
| * | K941780 | Orthovita BiogranSummary page 1…augmentation based upon additional clinical data and determination of substantial equivalence to the legally marketed device Orthovita- Biogran™ (Ref. [510(k)]# K952922, K941780). To confirm safety and efficacy, a recently completed human clinical study in extraction sites demonstrated favorable results f… | 1995 |
| * | — | Hapset™ Named without a submission number | |
| * | — | Osteogen® Named without a submission number | |
| * | — | Periograf® Named without a submission number |
What descends from it? (158)
See all 1587 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033994 | Novabone-BBG-Resorbable Bone Graft Substitute | 2004 | 85 |
| K040278 | Perioglas-Bioglass Bone Graft Substitute | 2004 | 80 |
| K053387 | Perioglas Bone Graft Particulate | 2006 | 13 |
| K063596 | Perioglas Putty-Bioactive Bone Graft Gel | 2007 | 4 |
| K063549 | Novabone Dental Putty-Bioactive Synthetic Bone Graft | 2007 | 2 |
| K031073 | Perioglas Plus - Settable Bone Graft Substitute | 2003 | 1 |
| 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?
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?
Perioglaso is indicated for use in infraboney pockets caused by periodontal disease.
The intended uses have been extended to extraction sites and ridge augmentation
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962494 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962494: Perioglas - Bioglass Bone Graft Particulate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962494
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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