510(k) · Cleared
ClearedModification to: Osteograf/N-700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · LYC Bone Grafting Material, Synthetic
Cleared on Aug 3, 2007 as substantially equivalent to K981214 (Ceramed Dental, LLC, 1998) and 2 other predicates after an 8-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 3, 2007
- Review
- 8 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K921469 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK921469 Osteograf/N-700 Natural Hydroxylapatite 18-40 MeshCeramed Corp. · 1992
- This deviceK072058 Modification to: Osteograf/N-700Dentsply Interntional · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921469 | Osteograf/N-700 Natural Hydroxylapatite 18-40 Mesh | Ceramed Corp. | 1992 | — |
| 0 (this device) | K072058 | Modification to: Osteograf/N-700 | Dentsply Interntional | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 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? (3)
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 |
|---|---|---|---|
| * | K981214 | Osteograf/N-700Summary page 1…E: OsteoGraf/N-700 CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/N-700, (K981214, K960368, K921469) DEVICE DESCRIPTION: The OsteoGraf/N-700 material is a high purity, high density, non- resorbable, radiopaque… | 1998 |
| * | K960368 | Osteograft/N-700 HydroxylaptiteSummary page 1…OsteoGraf/N-700 CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/N-700, (K981214, K960368, K921469) DEVICE DESCRIPTION: The OsteoGraf/N-700 material is a high purity, high density, non- resorbable, radiopaque, polycry… | 1996 |
| * | K921469 | Osteograf/N-700 Natural Hydroxylapatite 18-40 MeshSummary page 1…OsteoGraf/N-700 CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/N-700, (K981214, K960368, K921469) DEVICE DESCRIPTION: The OsteoGraf/N-700 material is a high purity, high density, non- resorbable, radiopaque, polycrystalline… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 ancestors has a recall.
- 2 other devices also cite its predicate K981214.
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?
OsteoGraf/N-700 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.
These are the same indications for use previously cleared for K981214, K960368, K921469
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072058: Modification to: Osteograf/N-700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072058
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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