510(k) · Cleared
ClearedOcs-B Collagen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nibec Co., Ltd. · NPM Bone Grafting Material, Animal Source
Cleared on Jul 31, 2015 as substantially equivalent to K092428 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2010) after a 368-day review. Its family tree reaches back 3 generations to 1987. 2 later devices descend from it.
- Decided
- Jul 31, 2015
- Review
- 368 days
- Class
- Class II
- Product code
- NPM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871773 (1987). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
- 2 generations backK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
- 1 generation backK092428 Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie · 2010
- This deviceK142040 Ocs-B CollagenNibec Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK254210 Rebohil (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK221808 InterOss CollagenSigmagraft, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871773 | Bio-Oss Pure Nat Hydroxyapatite Endoss Implant | Geistlich-Pharma | 1987 | — |
| −2 | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | Geistlich-Pharma | 2004 | — |
| −1 | K092428 | Bio-Oss Collagen | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2010 | — |
| 0 (this device) | K142040 | Ocs-B Collagen | Nibec Co., Ltd. | 2015 | — |
| +1 | K254210 | Rebohil (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | Hyundai Bioland Co., Ltd. | 2026 | — |
| +1 | K221808 | InterOss Collagen | Sigmagraft, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K092428 | Bio-Oss CollagenSummary page 4…ssification Name: Bone Filling Material Bone grafting material, animal source (NPM) Predicate devices ® Bio-Oss Collagen (K092428) (Primary Predicate) Manufactured by: Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 W olhusen Switzerland ® OCS-B (K11324… | 2010 |
| † | K113246 | OCS-B | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K254210 (Hyundai Bioland Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K092428.
How does its category compare?
All NPM devicesNPM Bone Grafting Material, Animal Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NPM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPM
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPM
14in 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?
OCS-B Collagen ® is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-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/K142040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142040: Ocs-B Collagen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142040
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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