510(k) · Cleared

Cleared

Cytoplast GBR

K964342510(k) TraditionalCleared Mar 11, 1997131-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

Osteogenics Co. · LYC Bone Grafting Material, Synthetic

Cleared on Mar 11, 1997 as substantially equivalent to K922627 (W. L. Gore & Associates, Inc., 1994) and 2 other predicates after a 131-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.

Decided: Mar 11, 1997
Review: 131 days
Class: Class II
Product code: LYC
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K922627 (1994). 3 ancestors in all. 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
This deviceK964342 Cytoplast GBROsteogenics Co. · 1997
Descendant · cites it directly · 7 of its ownK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
Descendant · 2 generations on · 2 of its ownK143327 Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015
Descendant · cites it directly · 2 of its ownK012144 CytoflexUnicare Biomedical, Inc. · 2001
Descendant · 2 generations on · 1 of its ownK201187 Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021
Descendant · 2 generations on · 1 of its ownK160493 Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg…Salvin Dental Specialties · 2016

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1997high 2 (2015) · low 0 (1998)2026

Most influential descendants

Showing 5 of 11 · See all

K972278Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · cites it directly7descendants
K143327Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015 · 2 generations on2descendants
K012144CytoflexUnicare Biomedical, Inc. · 2001 · cites it directly2descendants
K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021 · 2 generations on1descendant
K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE…Salvin Dental Specialties · 2016 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922627	Gore-Tex Regenerative Material	W. L. Gore & Associates, Inc.	1994	—
0 (this device)	K964342	Cytoplast GBR	Osteogenics Co.	1997	—
+1	K972278	Cytoplast Regentex Titanium 250	Osteogenics Co.	1997	1
+2	K143327	Neoss Ti Reinforced Membrane	Neoss, Ltd.	2015	—
+1	K012144	Cytoflex	Unicare Biomedical, Inc.	2001	—
+2	K201187	Cytoplast Titanium-Reinforced PTFE Membranes	Osteogenics Biomedical, Inc.	2021	—
+2	K160493	Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable…	Salvin Dental Specialties	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2001	1	0
2010	1	0
2011	1	0
2015	2	0
2016	1	0
2021	1	0
2022	1	0
2023	2	0

FIG. 1 — Lineage of K964342, 1994–2023Source: 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? (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
*	K922627	Gore-Tex Regenerative Material Summary page 1 …Non-Absorbable Barrier Membrane Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation. il. PREDICATE DEVICES Gore-Tex™ Regenerative Material (K922627; W.L Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) Imtec Biobarrier Membrane (K950306; Imtec Corporation)…	W. L. Gore & Associates, Inc.	1994	—
*	K935137	Tefgen-FD Summary page 1 …Name: Implant, Endosseous For Bone Filling And/Or Augmentation. il. PREDICATE DEVICES Gore-Tex™ Regenerative Material (K922627; W.L Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) Imtec Biobarrier Membrane (K950306; Imtec Corporation) IV. DEVICE DESCRIPTION The Cytoplast™ GBR Non-…	American Custom Medical, Inc.	1994	1
*	K950306	Imtec Biobarrier Summary page 1 …n. il. PREDICATE DEVICES Gore-Tex™ Regenerative Material (K922627; W.L Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) Imtec Biobarrier Membrane (K950306; Imtec Corporation) IV. DEVICE DESCRIPTION The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high de…	Imtec Corp.	1996	—

Also cleared against K922627: 1 other device →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K972278	Cytoplast Regentex Titanium 250	Osteogenics Co.	1997	7
K012144	Cytoflex	Unicare Biomedical, Inc.	2001	2

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K972278 (Osteogenics Co., 1997) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K922627.

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?

A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

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

https://510kreport.com/device/K964342 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964342: Cytoplast GBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964342

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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