← Product Code OLR · K112568 # AONGEN DENTAL COLLAGEN MATRIX (K112568) _Aeon Astron Europe B.V. · OLR · Mar 1, 2012 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K112568 ## Device Facts - **Applicant:** Aeon Astron Europe B.V. - **Product Code:** OLR - **Decision Date:** Mar 1, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended 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. ## Device Story Aongen™ Dental Collagen Matrix is a sterile, single-use, resorbable matrix composed of porcine type I collagen and glycosaminoglycan (GAG). GAG facilitates water absorption. The device is applied as an onlay to cover open wound defects in dental surgical sites. It functions as a scaffold to create an environment conducive to the natural wound healing process. The device is intended for use by dental professionals during surgical procedures. It provides a physical barrier and matrix support to aid in tissue repair, potentially accelerating healing and improving patient outcomes post-surgery. ## Clinical Evidence Bench testing only. Biocompatibility testing included Agar Diffusion (non-cytotoxic), Salmonella/E. coli reverse mutation (non-mutagenic), rodent bone marrow micronucleus (non-clastogenic), rabbit blood hemolysis (non-hemolytic), intramuscular implantation (no local toxic effects), intracutaneous injection (negligible irritant), Kligman maximization (no sensitization), rabbit pyrogen (non-pyrogenic), systemic injection (no toxic effects), and heavy metal testing. Sterility and LAL testing (<0.5 EU/mL) were also performed. ## Technological Characteristics Resorbable matrix composed of porcine type I collagen and glycosaminoglycan. Supplied sterile for single use. Functions as a scaffold for wound healing. No electronic, software, or mechanical components. ## Regulatory Identification Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ. ## Predicate Devices - OTA Collagen Biomaterial ([K073685](/device/K073685.md)) - Integra Meshed Bilayer Wound Matrix ([K081635](/device/K081635.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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}------------------------------------------------ K112568 #### 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 | <0.5 EU/mL | {2}------------------------------------------------ K112568 Comparison with the Predicates: | Device Name | Aongen™ Dental Collagen
Matrix | Integra Meshed Bilayer Wound
Matrix | |--------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Submitter | Aeon Astron Europe B.V. | Integra Lifesciences Corp. | | 510(k) No. | | K081635 | | Similarities | Both devices are comprised of a Collagen-GAG matrix which
creates a suitable environment for wound healing process. | | | Differences | Integra Meshed Bilayer Wound Matrix has an extra layer of
temporary semi-permeable silicone membrane. | | | Device Name | Aongen™ Dental Collagen
Matrix | OTA Collagen Biomaterial | |--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | Submitter | Aeon Astron Europe B.V. | Osseous Technologies of
America, Inc. | | 510(k) No. | K073685 | | | Similarities | Both devices are applied as an onlay to cover wound defects. | | | Differences | The source of collagen is different in these two devices.
Aongen™ Dental Collagen Matrix is sourced from porcine, and
OTA Collagen Biomaterial is sourced from bovine. | | ## Conclusion of Tests: The results of product characterization studies and biocompatibility studies demonstrate that Aongen™ Dental Collagen Matrix is substantially equivalent to the predicate devices. 39 3 {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The symbol is black, and the text is also in a dark color, likely black or a dark shade of gray. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAR - 1 2012 Mr. Horng Ji Lai CEO Aeon Astron Europe B.V. Niels Bohrweg 11-13 Leiden NETHERLANDS 2333 CA Re: K112568 Trade/Device Name: Aongen™ Dental Collagen Matrix Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MQN Dated: February 23, 2012 Received: February 27, 2012 Dear Mr. Lai: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Mr. Lai Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 106/ K112568 # Indications for Use 510(k) Number (if known): Device Name: Aongen™ Dental Collagen Matrix 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. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Susan Runne Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number. K112576 --- **Source:** [https://fda.innolitics.com/device/K112568](https://fda.innolitics.com/device/K112568) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com