510(k) · Cleared

Cleared

Frios Algipore

K023799510(k) TraditionalCleared Feb 5, 200383-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

Friadent GmbH · LYC Bone Grafting Material, Synthetic

Cleared on Feb 5, 2003 as substantially equivalent to K950165 (Interpore Intl., 1995) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Feb 5, 2003
Review: 83 days
Class: Class II
Product code: LYC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K950165 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK950165 Interpore IP 200 Granular Coralline Hydroxyapatite Bone Void…Interpore Intl. · 1995
This deviceK023799 Frios AlgiporeFriadent GmbH · 2003
Descendant · cites it directly · 0 of its ownK033110 C-GraftThe Clinician'S Preference, LLC · 2003

Most influential descendants

Showing 1 of 1 · See all

K033110C-GraftThe Clinician'S Preference, LLC · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950165	Interpore IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to…	Interpore Intl.	1995	—
0 (this device)	K023799	Frios Algipore	Friadent GmbH	2003	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K023799, 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K950165	Interpore IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000… Summary page 1 …F PREDICATE DEVICES ComDanv Device 510(k) No. Date Cleared Interpore Imterpore@ 200 Granular K950 165 03/28/1995 International Coralline Hydroxylapatite CeraMed Dental OsteoGram / N-700…	Interpore Intl.	1995	—
*	K981214	Osteograf/N-700 Summary page 1 …erpore@ 200 Granular K950 165 03/28/1995 International Coralline Hydroxylapatite CeraMed Dental OsteoGram / N-700 K98 12 14 06/26/1998 245 FRIA…	Ceramed Dental, LLC	1998	—

Also cleared against K950165: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K033110	C-Graft	The Clinician'S Preference, LLC	2003	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?

None of the 2 ancestors has a recall.
Of its descendants, K033110 (The Clinician'S Preference, LLC, 2003) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K950165.

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?

FRIOSB ALGPOWB is indicated for:

Treatment of intrabony defects

Augmentation of bony defects of alveolar ridge

Filling of extraction sites

Sinus elevation grafting

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023799 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023799: Frios Algipore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023799

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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