A concrete example shows the relevant specifications
The FDA record for Collagen Dental Membrane IV describes a resorbable membrane made from purified type I and III bovine collagen. It is supplied sterile for single use and is intended for guided bone and tissue regeneration in specified dental settings. [1]
Its barrier function and surgical placement are central to that use. Those features cannot be reproduced merely by swallowing collagen powder. [1]
One clearance does not describe every collagen material
This historical device record illustrates a particular membrane, not every brand or surgical situation. Source material, handling and intended use must be checked for the exact device. [1]
A 510(k) clearance should not be rewritten as a blanket claim that all collagen products are FDA-approved or clinically interchangeable. The dental clinician determines the procedure and follow-up. [1]
Match evidence to the route and purpose
Imagine a supplement advertisement cites a dental membrane record. Evidence about a surgically placed barrier does not establish an oral supplement benefit.
| Detail | Interpretation |
|---|---|
| Membrane | Local surgical barrier |
| Oral powder | Different route and purpose |
| Device record | Applies to a specific product |
Sources for this article
- FDA K090216: Collagen Dental Membrane IV
Source consulted: 2026-09-17. This is a reference resource, not a claim that we conducted the studies or tested a product.