K171050 is an FDA 510(k) clearance for the Geistlich Fibro-Gide. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.
Submitted by Geistlich Pharma AG (Wolhusen, Lu, CH). The FDA issued a Cleared decision on November 9, 2017 after a review of 216 days - an extended review cycle.
This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.
View all Geistlich Pharma AG devices
NCT02356770
Completed
Interventional
Industry-sponsored
A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants
Randomized Controlled Clinical Study to Investigate Effectiveness and Safety of a Collagen Matrix 10808 for Soft Tissue Volume Augmentation After Implant Placement in Single Tooth Gaps
| Condition studied |
Tooth Loss; Soft Tissue Deficiency |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Lorenz Uebersax, PhD |
| Sponsor |
Geistlich Pharma AG
(industry)
|
Started 2012-02-01
→
Primary completion 2013-07-01
Primary outcome
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
Secondary outcome
Assessment of Adverse Events
Study completed - no results published.
This trial concluded in 2013 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov