510(k) · Cleared

Cleared

C-Graft

K033110510(k) TraditionalCleared Dec 10, 200371-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

The Clinician'S Preference, LLC · LYC Bone Grafting Material, Synthetic

Cleared on Dec 10, 2003 as substantially equivalent to K023799 (Friadent GmbH, 2003) and 2 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1995.

Decided: Dec 10, 2003
Review: 71 days
Class: Class II
Product code: LYC
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K950165 (1995). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK950165 Interpore IP 200 Granular Coralline Hydroxyapatite Bone Void…Interpore Intl. · 1995
1 generation backK023799 Frios AlgiporeFriadent GmbH · 2003
This deviceK033110 C-GraftThe Clinician'S Preference, LLC · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K950165	Interpore IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to…	Interpore Intl.	1995	—
−1	K023799	Frios Algipore	Friadent GmbH	2003	—
0 (this device)	K033110	C-Graft	The Clinician'S Preference, LLC	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K033110, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K023799	Frios Algipore Summary page 1 …droxylapatite CeraMed OsteoGraf® / N-700 K981214 06/26/1998 Dental Friadent FRIOS® ALGIPORE® K023799 02/05/2003 GMBH 280 The Clinician's Prefere…	Friadent GmbH	2003	—
*	K950165	Interpore IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000… Summary page 1 …IFICATION OF PRECATE DEVICES Company Device 510(k) No. Date Cleared Interpore Interpore® 200 Granular K950165 03/28/1995 International Coralline Hydroxylapatite CeraMed OsteoGraf® / N-700…	Interpore Intl.	1995	—
*	K981214	Osteograf/N-700 Summary page 1 …Interpore® 200 Granular K950165 03/28/1995 International Coralline Hydroxylapatite CeraMed OsteoGraf® / N-700 K981214 06/26/1998 Dental Friadent FRIOS® ALGIPORE® K023799 02/05/2003…	Ceramed Dental, LLC	1998	—

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
None of the 3 ancestors has a recall.

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

2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007high 267 (2025) · low 73 (2008)2026

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

Recalls per year · LYC

1in 2018

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

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

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?

C-GRAFTTM is indicated for:

Augmentation of bony defects of the alveolar ridge

Sinus elevation grafting

Treatment of intrabony periodontal defects

Extraction socket grafting

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033110 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033110: C-Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033110

Report an extraction error

Are you the manufacturer?

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