510(k) · Cleared
ClearedGuidor Bioresorbable Matrix Barrier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunstar Americas, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Oct 29, 2013 as substantially equivalent to K912724 (Procordia Oratech AB, 1993) and 5 other predicates after a 95-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Oct 29, 2013
- Review
- 95 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K924408 (1995). 15 ancestors in all, the oldest K912724 (1993). No later device cites it as a predicate yet.
- 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 deviceK132325 Guidor Bioresorbable Matrix BarrierSunstar Americas, Inc. · 2013
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) | K132325 | Guidor Bioresorbable Matrix Barrier | Sunstar Americas, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 NPK? 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 NPK device
- #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K912724 | Guidor (TM)Summary page 1…1 CFR 872.3930 Product Codes: NPK Predicate Device(s): Guidorrm, Sunstar Suisse SA (originally submitted by Procordia OraTech AR) (K9 12724) Resolut® Adapt LT Regenerative Membrane, WL Gore (KOS51267) Inion GTR Biodegra… | 1993 |
| * | K051267 | Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore…Summary page 3…posed of synthetic materials similar to the Guidoffm predicate (K912724), Inion GTR Biodegradable Membrane System (K033074), and Resolut® Adapt LT Regenerative Membrane (K05 1267) predicates, while the remaining predicates are composed of collagen. The applicant and predicate devices have all been… | 2005 |
| * | K033074 | Inion GTR Biodegradable Membrane SystemSummary page 1…12724) Resolut® Adapt LT Regenerative Membrane, WL Gore (KOS51267) Inion GTR Biodegradable Membrane System. Inion Ltd (K033074) Bio-Gide Resorbable Bilayer Membrane, Ed. Geistlich Soehne Ag Fuer Chemische I… | 2004 |
| * | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneSummary page 1…ane System. Inion Ltd (K033074) Bio-Gide Resorbable Bilayer Membrane, Ed. Geistlich Soehne Ag Fuer Chemische Industrie (K050446) CytoplaStTm Resorb. Osteogenics Biomedical, Inc. (K993610) Ossix Plus, ColBar… | 2005 |
| * | K993610 | Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250Summary page 1…Membrane, Ed. Geistlich Soehne Ag Fuer Chemische Industrie (K050446) CytoplaStTm Resorb. Osteogenics Biomedical, Inc. (K993610) Ossix Plus, ColBar LifeScience Ltd. (K053260) Device Description: The GUIDOR® Bioresorbable Matrix Ba… | 2000 |
| * | K053260 | Ossix -PlusSummary page 1…che Industrie (K050446) CytoplaStTm Resorb. Osteogenics Biomedical, Inc. (K993610) Ossix Plus, ColBar LifeScience Ltd. (K053260) Device Description: The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacrs between the lay… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 4 of the 15 ancestors have a recall of any class.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NPK
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPK
529in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPK
No recall names NPK since 2007.
Adverse event reports per year · NPK
3in 2022
MAUDE reports naming product code NPK, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 529 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
GBR Configurations
To aid in bone regeneration and augmentation in oral surgery for:
- Extraction socket site preservation
- Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desired,
- Ridge augmentation
- Sinus elevation
- Stable barrier for the containment of bone grafting materials
GTR Configurations
To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planing for:
- Class II furcations
- intrabony defects
- recession type defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132325: Guidor Bioresorbable Matrix Barrier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132325
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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