(177 days)
Not Found
No
The summary describes a resorbable collagen matrix for wound healing and does not mention any AI or ML components or functions.
Yes
The device is described as a resorbable material that aids in wound healing post-surgery, which is a therapeutic function.
No
This device is a resorbable material used in dental surgical procedures to aid in wound healing, not to diagnose a condition.
No
The device description clearly states it is a "resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery." This describes a device used in vivo (within the body) to support a physiological process (wound healing).
- Device Description: The description details a "resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan." This is a material implanted or applied directly to tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device's function is to physically support wound healing within the body.
N/A
Intended Use / Indications for Use
Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.
Product codes (comma separated list FDA assigned to the subject device)
MGQ, MQN
Device Description
Aongen™ Dental Collagen Matrix is a white, resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan. The function of glycosaminoglycan is water absorption. The device is supplied sterile and for single use only. Aongen™ Dental Collagen Matrix functions in a manner similar to the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were conducted to evaluate the biocompatibility and performance of Aongen™ Dental Collagen Matrix. The results of these tests demonstrate that Aongen™ Dental Collagen Matrix is safe and biocompatible.
Biocompatibility Tests conducted included: Agar Diffusion Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, Rodent Bone Marron Micronucleus Assay, Hemolysis - Rabbit Blood, Intramuscular Implantation Test, Intracutaneous Injection Test, Kligman Maximization Test, Rabbit Pyrogen Test, Systemic Injection Test, Heavy Metal Test, and Sterility Test, LAL Test.
Key results: Agar Diffusion Test: Non-cytotoxic; Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay: Not mutagenic; Rodent Bone Marrow Micronucleus Assay: Non-clastogenic; Hemolysis – Rabbit Blood: Non-hemolytic; Intramuscular Implantation Test: No local toxic effects after implantation; Intracutaneous Injection Test: Negligible irritant; Kligman Maximization Test: No sensitization; Rabbit Pyrogen Test: Non-pyrogenic; Systemic Injection Test: No toxic effects; Heavy Metal Test: Within acceptance level; Sterility Test: Sterile; LAL Test:
N/A
0
KI12568
510(k) Summary
MAR - 1 2012
Submitter Name and Address:
Aeon Astron Europe B.V. Niels Bohrweg 11-13, 2333 CA Leiden, The Netherlands
Contact Person:
Horng Ji Lai C.E.O. Tel: +31-71-3322280 Fax: +31-71-3322281
Date Prepared:
February 23, 2012
Device Information:
| Proprietary Name: | Aongen™ Dental Collagen Matrix |
|---|---|
| Product Code: | MGQ |
| Device Class: | Unclassified |
| Review Panel: | General & Plastic Surgery |
Predicate Device:
| Predicate #1 | |
|---|---|
| Proprietary Name: | OTA Collagen Biomaterial |
| Common Name: | Collagen dental membrane |
| Product Code: | NPL |
| 510(k) Number: | K073685 |
| 510(k) Submitter: | Osseous Technologies of America, Inc. |
Predicate #2
| Proprietary Name: | Integra Meshed Bilayer Wound Matrix |
|---|---|
| Common Name: | N/A |
| Product Code: | FRO |
| 510(k) Number: | K081635 |
| 510(k) Submitter: | Integra Lifesciences Corp. |
1
Device Description:
Aongen™ Dental Collagen Matrix is a white, resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan. The function of glycosaminoglycan is water absorption. The device is supplied sterile and for single use only. Aongen™ Dental Collagen Matrix functions in a manner similar to the predicates.
Indications for Use:
Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.
Summary of Tests:
Tests were conducted to evaluate the biocompatibility and performance of Aongen™ Dental Collagen Matrix. The results of these tests demonstrate that Aongen™ Dental Collagen Matrix is safe and biocompatible.
| Biocompatibility Tests | Result |
|---|---|
| Agar Diffusion Test | Non-cytotoxic |
| Salmonella Typhimurium and Escherichia | |
| Coli Reverse Mutation Assay | Not mutagenic |
| Rodent Bone Marrow Micronucleus Assay | Non-clastogenic |
| Hemolysis – Rabbit Blood | Non-hemolytic |
| Intramuscular Implantation Test | No local toxic effects after implantation |
| Intracutaneous Injection Test | Negligible irritant |
| Kligman Maximization Test | No sensitization |
| Rabbit Pyrogen Test | Non-pyrogenic |
| Systemic Injection Test | No toxic effects |
| Heavy Metal Test | Within acceptance level |
| Sterility Test | Sterile |
| LAL Test |