510(k) Report

510(k) · Cleared

Cleared

Perioglas- Bioglass Bone Graft Particulate

K992416510(k) TraditionalCleared Oct 15, 199987-day reviewClass II21 CFR 872.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Usbiomaterials Corp. · LYC Bone Grafting Material, Synthetic

Cleared on Oct 15, 1999 as substantially equivalent to K852682 (Calcitek, Inc., 1985) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1985. 189 later devices descend from it.

Decided
Oct 15, 1999
Review
87 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K852682 (1985). 2 ancestors in all. 189 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2008: 8 descendants cleared2007: 8 descendants cleared2004: 3 descendants cleared2003: 3 descendants cleared2011: 8 descendants cleared2005: 2 descendants cleared2006: 5 descendants cleared2010: 9 descendants cleared2025: 20 descendants cleared2016: 5 descendants cleared2009: 10 descendants cleared2012: 6 descendants cleared2013: 4 descendants cleared2014: 8 descendants cleared2015: 5 descendants cleared2026: 14 descendants cleared2019: 7 descendants cleared2018: 8 descendants cleared2021: 8 descendants cleared2023: 14 descendants cleared2020: 2 descendants cleared2024: 17 descendants cleared2022: 9 descendants cleared2017: 6 descendants clearedK852682 · Calcitite Bone Graft Mat/Oral & Maxillofacial Surg · Calcitek, Inc. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 10 descendants2 generations forward: 34 descendants3 generations forward: 21 descendants4 generations forward: 40 descendants5 generations forward: 40 descendants6 generations forward: 16 descendants7 generations forward: 15 descendants8 generations forward: 9 descendants9 generations forward: 3 descendants10 generations forward: 1 descendant K852682 · Calcitite Bone Graft Mat/Oral & Maxillofacial Surg · Calcitek, Inc. · 19850+5+10
  1. Root · 1 generation backK852682 Calcitite Bone Graft Mat/Oral & Maxillofacial SurgCalcitek, Inc. · 1985
  2. This deviceK992416 Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1999
  3. Descendant · cites it directly · 85 of its ownK033994 Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  4. Descendant · 2 generations on · 84 of its ownK041613 Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC · 2004
  5. Descendant · cites it directly · 80 of its ownK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
  6. Descendant · 3 generations on · 59 of its ownK082672 Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC · 2008
  7. Descendant · 4 generations on · 47 of its ownK101860 Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC · 2010

Showing 5 of 189 descendants. See all descendants

Descendants cleared per year

2003: 32004: 32005: 22006: 52007: 82008: 82009: 102010: 92011: 82012: 62013: 42014: 82015: 52016: 52017: 62018: 82019: 72020: 22021: 82022: 92023: 142024: 172025: 202026: 14
2003high 20 (2025) · low 2 (2005)2026

Most influential descendants

Showing 5 of 189 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K852682Calcitite Bone Graft Mat/Oral & Maxillofacial SurgCalcitek, Inc.1985—
0 (this device)K992416Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp.1999—
+1K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC2004—
+2K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC2004—
+1K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC2004—
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC2008—
+4K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200330
200430
200520
200650
200780
200880
2009100
201090
201180
201260
201340
201480
201550
201650
201760
201880
201970
202020
202180
202290
2023140
2024170
2025200
2026140
FIG. 1 — Lineage of K992416, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K852682Calcitite Bone Graft Mat/Oral & Maxillofacial Surg
Summary page 1
…ct. Predicate Device PerioGlas® is substantially equivalent to legally marketed osteoconductive bone filling and/or augmentatlon devices in the U.S. mcludmg Calcitite (K852682) and Bio-Oss (K970321). Any minor differences between PerioGlas® and the predicate devices do not raise new questions of safety o…
Calcitek, Inc.1985—
*K970321Bio-Oss Anorganic Bovine Bone
Summary page 1
…PerioGlas® is substantially equivalent to legally marketed osteoconductive bone filling and/or augmentatlon devices in the U.S. mcludmg Calcitite (K852682) and Bio-Oss (K970321). Any minor differences between PerioGlas® and the predicate devices do not raise new questions of safety or effectiveness. Inte…
Geistlich-Pharma1998—

Also cleared against K852682: 1 other device →

What descends from it? (189)

See all 189

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033994Novabone-BBG-Resorbable Bone Graft SubstituteNovabone Products, LLC200485
K040278Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC200480
K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518
K073070Dio Biotite-H Implant SystemDio Department Dsi, Inc.200816
K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc.200315
K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613
K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074
K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072
K031073Perioglas Plus - Settable Bone Graft SubstituteNovabone Products, LLC20031
K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K033994 (Novabone Products, LLC, 2004) has gone furthest, with 85 descendants of its own.
  • 1 other device also cites its predicate K852682.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

What is it indicated for?

The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses incluge:

Periodontal/Infrabony defects

Ridge augmentation

Extraction sites

Cranio-facial augmentation

Cystic cavities

Sinus lifts

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K852682

1 other device cites the same predicate.

  • K030682Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3Bioform, Inc. · 2003

More from Usbiomaterials Corp.

5 FDA decisions under this applicant name. See the company

  • K024343Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
  • K000149Novabone-Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 2000
  • K962494Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
  • K930115PerioglassUsbiomaterials Corp. · 1993

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K992416 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992416: Perioglas- Bioglass 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/K992416

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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