510(k) Report

510(k) · Cleared

Cleared

Biomesh Biodegradable GTR Barrier

K990363510(k) TraditionalCleared Apr 9, 199963-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

Samyang Corp. · NPK Barrier, Synthetic, Intraoral

Cleared on Apr 9, 1999 as substantially equivalent to K932866 (W. L. Gore & Associates, Inc., 1995) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided
Apr 9, 1999
Review
63 days
Class
Class II
Product code
NPK
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K932866 (1995). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor2009: 1 descendant cleared2026: 1 descendant clearedK932866 · Resolut Regenerative Material · W. L. Gore & Associates, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K932866 · Resolut Regenerative Material · W. L. Gore & Associates, Inc. · 19950
  1. Root · 1 generation backK932866 Resolut Regenerative MaterialW. L. Gore & Associates, Inc. · 1995
  2. This deviceK990363 Biomesh Biodegradable GTR BarrierSamyang Corp. · 1999
  3. Descendant · cites it directly · 1 of its ownK090083 Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009
  4. Descendant · 2 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc. · 2009 · cites it directly1descendant
  • K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K932866Resolut Regenerative MaterialW. L. Gore & Associates, Inc.1995—
0 (this device)K990363Biomesh Biodegradable GTR BarrierSamyang Corp.1999—
+1K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc.2009—
+2K253317Cytrans™ ElashieldGC America, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
202610
FIG. 1 — Lineage of K990363, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K932866Resolut Regenerative Material
Summary page 1
…Predicate Device: SAMYANG CORPORATION believes that BioMesh® Biodegradable GTR Barrier is substantially equivalent to Resolut Regenerative Material as characterized in K932866, K962624 and K973594. 1. Gore Resolut Regenerative Material, K932866, K962624 & K973594 Comparison of BioMesh® Biodegradable GT…
W. L. Gore & Associates, Inc.1995—
*K962624Resolut Regenerative Material
Summary page 1
…e Device: SAMYANG CORPORATION believes that BioMesh® Biodegradable GTR Barrier is substantially equivalent to Resolut Regenerative Material as characterized in K932866, K962624 and K973594. 1. Gore Resolut Regenerative Material, K932866, K962624 & K973594 Comparison of BioMesh® Biodegradable GTR Barrier…
W. L. Gore & Associates, Inc.1996—
*K973594Gore Resolut XT Regenerative Material
Summary page 1
…AMYANG CORPORATION believes that BioMesh® Biodegradable GTR Barrier is substantially equivalent to Resolut Regenerative Material as characterized in K932866, K962624 and K973594. 1. Gore Resolut Regenerative Material, K932866, K962624 & K973594 Comparison of BioMesh® Biodegradable GTR Barrier brand GTR b…
W. L. Gore & Associates, Inc.1997—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090083Cytoflex Resorb, Model C03-0010 Through C03-090Unicare Biomedical, Inc.20091

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K090083 (Unicare Biomedical, Inc., 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All NPK devices

NPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NPK

3in 2023

2009: 12010: 22011: 12013: 12015: 22016: 12017: 12021: 12022: 12023: 3
2007high 3 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPK

529in 2023

2023: 529 days median
2007high 529 (2023)2026

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

2008: 12009: 22010: 132011: 352012: 172013: 62014: 12017: 12020: 12021: 22022: 3
2007high 35 (2011) · low 0 (2007)2025

MAUDE reports naming product code NPK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091—02
20102—013
20111—035
20120—017
20131—06
20140—01
20152—00
20161—00
20171—01
20180—00
20190—00
20200—01
20211—02
20221—03
2023352900
20240—00
20250—00
20260—0—

What is it indicated for?

BioMesh® Biodegradable GTR Barrier is indicated for use in the

treatment of the following specific conditions:

Two or three wall vertical defects.

Class Il furcations.

Circumferrential defects.

Recession type defects.

Dehisence defects associated with dental implants

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

More from Samyang Corp.

2 FDA decisions under this applicant name. See the company

  • K984374SurgisorbSamyang Corp. · 1999

Recent decisions in NPK

The NPK category page

  • K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais · 2023
  • K222549OpenTexPurgo Biologics, Inc. · 2023
  • K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd. · 2023
  • K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd. · 2022
  • K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021

https://510kreport.com/device/K990363 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990363: Biomesh Biodegradable GTR Barrier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990363

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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