510(k) · Cleared
ClearedVitala Natural Resorbable Collagen Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obi Biologics, Inc. · NPL Barrier, Animal Source, Intraoral
Cleared on Jul 21, 2011 as substantially equivalent to K050446 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2005) and 2 other predicates after a 422-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 422 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K924408 (1995). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- 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 deviceK101453 Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK141177 Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi · 2015
- Descendant · 2 generations on · 2 of its ownK173562 Straumann Jason MembraneInstitut Straumann AG · 2018
- Descendant · 3 generations on · 0 of its ownK242817 Jason membraneBotiss Biomaterials GmbH · 2025
- Descendant · 3 generations on · 0 of its ownK223912 InterCollagen® GuideSigmagraft, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K141177Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi · 2015 · cites it directly3descendants
- K173562Straumann Jason MembraneInstitut Straumann AG · 2018 · 2 generations on2descendants
- K242817Jason membraneBotiss Biomaterials GmbH · 2025 · 3 generations on0descendants
- K223912InterCollagen® GuideSigmagraft, Inc. · 2023 · 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) | K101453 | Vitala Natural Resorbable Collagen Membrane | Obi Biologics, Inc. | 2011 | — |
| +1 | K141177 | Vitala Porcine Derived Collagen Membrane | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 2015 | — |
| +2 | K173562 | Straumann Jason Membrane | Institut Straumann AG | 2018 | — |
| +3 | K242817 | Jason membrane | Botiss Biomaterials GmbH | 2025 | — |
| +3 | K223912 | InterCollagen® Guide | Sigmagraft, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
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 NPL? 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 NPL device
- #1 K212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape…score 14.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneSummary page 1…ls Guidance Document: Dental Bone Grafting Material Device) Predicate Devices: BiO-GIDE' (1(050446) CopiM Pericardium Membrane (K(073097) Device Description… | 2005 |
| * | K073097 | Tutodent Dental MembraneSummary page 1…Device) Predicate Devices: BiO-GIDE' (1(050446) CopiM Pericardium Membrane (K(073097) Device Description Osxh Pu K520 Vital" Resorbable Natural Collagen Membrane isa natural collagen… | 2008 |
| * | K053260 | Ossix -PlusSummary page 2…'-Plus (1(101453) (1(050446) (100730971 (1(053260) Os1Biologics, Inc. -Geistlich-pharm, RT Bi… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141177 | Vitala Porcine Derived Collagen Membrane | 2015 | 3 |
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 7 ancestors have a recall of any class.
- Of its descendants, K141177 (Osteogenics Biomedical, Inc. (Formerly Obi Biologi, 2015) has gone furthest, with 3 descendants of its own.
- 16 other devices also cite its predicate K050446.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NPL
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPL
132in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPL
6in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPL
39in 2025
MAUDE reports naming product code NPL, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 172 | 0 | 0 |
| 2009 | 3 | 193 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 4 | 286 | 0 | 0 |
| 2012 | 0 | — | 3 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 5 | 140 | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 184 | 0 | 9 |
| 2017 | 3 | 200 | 0 | 18 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 6 | 22 |
| 2020 | 2 | — | 0 | 8 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 290 | 0 | 19 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 3 | 263 | 0 | 20 |
| 2025 | 5 | 132 | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Vitala Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: * Simultaneous use with implants; * 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…
Read the full statement (144 words)
Vitala Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:
* Simultaneous use with implants;
* 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;
* Alveolar ridge preservation consequent to tooth extraction;
* Filling of bone defects after root resection, cystectomy, removal of retained teeth;
* Over the window in lateral window sinus elevation procedures;
* Furcation defects in multi-rooted teeth;
* Treatment of recession defects, together with coronally positioned flap;
* In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection;
* Guided bone regeneration in dehiscence defects; and
* Guided tissue regeneration in periodontal defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101453: Vitala Natural Resorbable Collagen Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101453
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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