510(k) · Cleared

Cleared

Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio

K112575510(k) TraditionalCleared Dec 27, 2011112-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

Geistlich Pharma AG · NPM Bone Grafting Material, Animal Source

Cleared on Dec 27, 2011 as substantially equivalent to K092428 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2010) and 5 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1995. 11 later devices descend from it.

Decided: Dec 27, 2011
Review: 112 days
Class: Class II
Product code: NPM
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K924408 (1995). 14 ancestors in all, the oldest K871773 (1987). 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
3 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
2 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
1 generation backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
This deviceK112575 Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG · 2011
Descendant · cites it directly · 10 of its ownK171643 Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG · 2017
Descendant · cites it directly · 9 of its ownK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
Descendant · 2 generations on · 3 of its ownK212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2022
Descendant · 2 generations on · 3 of its ownK210280 Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021
Descendant · 3 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2017high 4 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 11 · See all

K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG · 2017 · cites it directly10descendants
K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2019 · cites it directly9descendants
K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2022 · 2 generations on3descendants
K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021 · 2 generations on3descendants
K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K924408	Colla-Tec Absorbable Collagen Membrane	Colla-Tec, Inc.	1995	2
−3	K992216	Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen…	Integra Lifesciences Corp.	1999	1
−2	K042197	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2004	—
−1	K050446	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2005	—
0 (this device)	K112575	Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio	Geistlich Pharma AG	2011	—
+1	K171643	Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed	Geistlich Pharma AG	2017	—
+1	K192042	Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed…	Geistlich Pharma AG	2019	—
+2	K212463	Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed…	Geistlich Pharma AG	2022	—
+2	K210280	Geistlich Mucograft®, Geistlich Mucograft® Seal	Geistlich Pharma AG	2021	—
+3	K253317	Cytrans™ Elashield	GC America, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1992	1	0
1995	2	0
1997	1	0
1998	2	0
2000	1	0
2004	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2019	1	0
2021	1	0
2022	1	0
2023	1	0
2024	1	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K112575, 1995–2026Source: 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 NPM? 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 NPM device

#1 K240661 Geistlich Bio-Oss®score 15.2 · 6 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? (6)

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
*	K092428	Bio-Oss Collagen Summary page 1 …n Name: Bone grafting material, animal source (NPM) Barrier, animal source, intraoral (NPL) PREDICATE DEVICES Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K0421 97, K960724) DEVICE DESCRIPTION Geistlich Peria-System Combi-Pack…	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2010	—
*	K033815	Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen Summary page 1 …Bone grafting material, animal source (NPM) Barrier, animal source, intraoral (NPL) PREDICATE DEVICES Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K0421 97, K960724) DEVICE DESCRIPTION Geistlich Peria-System Combi-Pack is a conv…	Geistlich-Pharma	2004	—
*	K974399	Bio-Oss Collagen Summary page 1 …ne grafting material, animal source (NPM) Barrier, animal source, intraoral (NPL) PREDICATE DEVICES Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K0421 97, K960724) DEVICE DESCRIPTION Geistlich Peria-System Combi-Pack is a convenience k…	Geistlich-Pharma	1998	—
*	K050446	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Summary page 1 …, animal source (NPM) Barrier, animal source, intraoral (NPL) PREDICATE DEVICES Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K0421 97, K960724) DEVICE DESCRIPTION Geistlich Peria-System Combi-Pack is a convenience kit containing one un…	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2005	—
*	K042197	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration Summary page 1 …source (NPM) Barrier, animal source, intraoral (NPL) PREDICATE DEVICES Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K0421 97, K960724) DEVICE DESCRIPTION Geistlich Peria-System Combi-Pack is a convenience kit containing one unit of Geis…	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2004	—
*	K960724	Bio-Gide Resorbable Bilayer Membrane Summary page 1 …M) Barrier, animal source, intraoral (NPL) PREDICATE DEVICES Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K0421 97, K960724) DEVICE DESCRIPTION Geistlich Peria-System Combi-Pack is a convenience kit containing one unit of Geistlich Blo…	Geistlich-Pharma	1997	—

Also cleared against K092428: 3 other devices →

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
K171643	Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed	Geistlich Pharma AG	2017	10
K192042	Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…	Geistlich Pharma AG	2019	9

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 16 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
2 of the 14 ancestors have a recall of any class.
Of its descendants, K171643 (Geistlich Pharma AG, 2017) has gone furthest, with 10 descendants of its own.
3 other devices also cite its predicate K092428.

How does its category compare?

All NPM devices

NPM Bone Grafting Material, Animal Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NPM

3in 2025

2007high 5 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPM

30in 2025

2007high 349 (2015) · low 30 (2025)2026

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

Recalls per year · NPM

1in 2022

2007high 3 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NPM

14in 2025

2007high 27 (2022) · low 0 (2008)2025

MAUDE reports naming product code NPM, 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	0	—	0	1
2008	0	—	0	0
2009	1	—	0	0
2010	2	—	0	1
2011	3	112	0	0
2012	2	—	0	2
2013	2	—	0	3
2014	2	—	0	3
2015	4	349	0	1
2016	1	—	0	1
2017	5	191	0	3
2018	2	—	1	8
2019	0	—	0	6
2020	3	231	3	3
2021	2	—	0	4
2022	0	—	1	27
2023	2	—	0	4
2024	3	211	0	5
2025	3	30	0	14
2026	3	269	0	—

What is it indicated for?

Geistlich Bic-Gide Perio is intended for the following uses: - Augmentation around implants placed in immediate extraction sockets; - Augmentation around implants placed in delayed extraction sockets; - Localized ridge augmentation for later implantation; - Alveolar ridge reconstruction for prosthetic treatment; - Filling of bone defects after root resection, cystectomy, removal of retained teeth; - Guided bone regeneration in dehiscence defects; -…

Read the full statement (156 words)

Geistlich Bic-Gide Perio is intended for the following uses:

- Augmentation around implants placed in immediate extraction sockets;

- Augmentation around implants placed in delayed extraction sockets;

- Localized ridge augmentation for later implantation;

- Alveolar ridge reconstruction for prosthetic treatment;

- Filling of bone defects after root resection, cystectomy, removal of retained teeth;

- Guided bone regeneration in dehiscence defects;

- Guided tissue regeneration procedures in periodontal defects.

Geistlich Blo-Oss Collagen® is intended for the following uses:

- Augmentation or reconstructive treatment of the alveolar ridge;

- Filling of periodontal defects;

- Filling of defects after root resection, apicoectomy, and cystectomy;

- Filling of extraction sockets to enhance preservation of the alveolar ridge;

- Elevation of the maxillary sinus floor;

- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);

- Filling of peni-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112575 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112575: Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112575

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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