510(k) Report

510(k) · Cleared

Cleared

Osteograf/D-700

K072056510(k) SpecialCleared Aug 6, 200711-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

Dentsply International, Inc. · LYC Bone Grafting Material, Synthetic

Cleared on Aug 6, 2007 as substantially equivalent to K863176 (Coors Biomedical Co., 1986) and 3 other predicates after an 11-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.

Decided
Aug 6, 2007
Review
11 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K852742 (1985). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1986: 3 other ancestors2011: 1 descendant cleared2022: 1 descendant clearedK852742 · Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 · Coors Biomedical Co. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K852742 · Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 · Coors Biomedical Co. · 19850
  1. Root · 1 generation backK852742 Osteograf AR Alveolar Ridge Hydroxylapatite 18-40Coors Biomedical Co. · 1985
  2. This deviceK072056 Osteograf/D-700Dentsply International, Inc. · 2007
  3. Descendant · cites it directly · 1 of its ownK102872 Osbone DentalCurasan AG · 2011
  4. Descendant · 2 generations on · 0 of its ownK202675 InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K102872Osbone DentalCurasan AG · 2011 · cites it directly1descendant
  • K202675InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K852742Osteograf AR Alveolar Ridge Hydroxylapatite 18-40Coors Biomedical Co.1985—
0 (this device)K072056Osteograf/D-700Dentsply International, Inc.2007—
+1K102872Osbone DentalCurasan AG2011—
+2K202675InRoad® Dental Synthetic Bone GraftOsteogene Tech Corp2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198630

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
202210
FIG. 1 — Lineage of K072056, 1985–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K863176Additional Clinical Usages for Osteograf/AR & AR+
Summary page 1
…E: OsteoGraf/D-700 CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/D-700, K863176, K863234, K861084, K861083, K852742 DEVICE DESCRIPTION: The OsteoGraf/D-700 material is a…
Coors Biomedical Co.1986—
Kept off the family treeK863234OsteoGraf/D-700
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…OsteoGraf/D-700 CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/D-700, K863176, K863234, K861084, K861083, K852742 DEVICE DESCRIPTION: The OsteoGraf/D-700 material is a high puri…
*K861084Osteograf/AR Alveolar Rid Hydrox, 18-40 Mesh
Summary page 1
…OsteoGraf/D-700 CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/D-700, K863176, K863234, K861084, K861083, K852742 DEVICE DESCRIPTION: The OsteoGraf/D-700 material is a high purity, high…
Coors Biomedical Co.1986—
*K861083Osteograf/AR+(Plus) Alveolar Rid Hydrox 18-40 Mesh
Summary page 1
…Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/D-700, K863176, K863234, K861084, K861083, K852742 DEVICE DESCRIPTION: The OsteoGraf/D-700 material is a high purity, high density, non- resorbable, radiopaque, polycrys…
Coors Biomedical Co.1986—
*K852742Osteograf AR Alveolar Ridge Hydroxylapatite 18-40
Summary page 1
…Bone Grafting Material 21 CFR 872.3930 PREDICATE DEVICES: OsteoGraf/D-700, K863176, K863234, K861084, K861083, K852742 DEVICE DESCRIPTION: The OsteoGraf/D-700 material is a high purity, high density, non- resorbable, radiopaque, polycrystalline p…
Coors Biomedical Co.1985—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102872Osbone DentalCurasan AG20111

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 4 ancestors has a recall.
  • Of its descendants, K102872 (Curasan AG, 2011) has gone furthest, with 1 descendant of its own.

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. 2007, this device’s year, is highlighted.

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?

OsteoGraf/D-700 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filing of extraction sites.

These are the same indications for use previously cleared for K852742, K863176, and K862324.

Indications for use as stated in the FDA summary.

More from Dentsply International, Inc.

36 FDA decisions under this applicant name. See the company

  • K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
  • K160232Disposable Barrier Sleeves and CoversDentsply International, Inc. · 2016
  • K151439Atlantis IsusDentsply International, Inc. · 2016
  • K152247ATLANTIS CrownDentsply International, Inc. · 2016
  • K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc. · 2016

Recent decisions in LYC

The LYC category page

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https://510kreport.com/device/K072056 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072056: Osteograf/D-700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072056

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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