GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS

K102307 · Genoss Co., Ltd. · NPL · May 4, 2011 · Dental

Device Facts

• Record ID: K102307
• Device Name: GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
• Applicant: Genoss Co., Ltd.
• Product Code: NPL · Dental
• Decision Date: May 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

GENOSS Collagen Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane into bony defects surrounding teeth and on alveolar ridges. - Periodontal/infrabony defects - Ridge augmentation - Extraction sites (implant preparation/placement) - Guided bone regeneration (GBR) procedures - Sinus lifts

Device Story

GENOSS Collagen Membrane is a resorbable, passive barrier membrane derived from bovine Type 1 collagen; used in oral surgery to exclude epithelial and gingival connective tissue from bone defect sites; allows desirable cells to repopulate the area for bone regeneration; eliminates need for second surgery due to resorbability; operated by dental professionals in clinical settings; provides physical separation to facilitate healing in periodontal defects, ridge augmentation, and sinus lifts.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing (ISO 10993: cytotoxicity, systemic toxicity, pyrogenicity, sensitization, intracutaneous reactivity, implantation, genotoxicity, haemocompatibility, elution assay) and in-vitro bench testing (shrink temperature, tensile strength, decomposition time, swelling). Raw material safety evaluated per ASTM F2212-08.

Technological Characteristics

Material: Type 1 bovine collagen. Crosslinking: Carbodiimide (EDC). Sterilization: Gamma irradiation. Form factor: Membrane sheets of varying dimensions (e.g., 10x20mm to 30x40mm) and 0.3mm thickness. Biocompatibility testing per ISO 10993; raw material safety per ASTM F2212-08.

Indications for Use

Indicated for patients requiring guided bone or tissue regeneration in oral cavity bony defects surrounding teeth or on alveolar ridges, including periodontal/infrabony defects, ridge augmentation, extraction sites, GBR procedures, and sinus lifts.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• RCM6 membrane (K003339)
• Fortgen Oral Membrane (K071555)
• OSSIX Plus (K053260)

Submission Summary (Full Text)

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Genoss Co., Ltd. 1F Gyeonggi R&DB center, 906-5 Iui-dong, Suwon-si, Yeongtong-gu, Gyeonggi-do, 433-270, Korea Tel. [phone], Fax. [phone], Web: www.genoss.com

Image /page/0/Picture/1 description: The image shows the text "MAY - 4 2011" on the top line. Below that is the word "GENOSS" in a bold, stylized font. The text appears to be a date and a company or product name.

# 510(k) Summary

## 1. Company

| | Submitter |
|----------------|-------------------------------------------------------------------------------------------------|
| Name | GENOSS Co., Ltd. |
| Address | 1F Gyeonggi R&DB center, 906-5 lui-dong, Suwon-si, Yeongtong-gu,<br>Gyeonggi-do, 433-270, Korea |
| Phone/Fax | [phone]/ [phone] |
| Contact Person | Hoseog Cha / QA Team leader<br>[e-mail] |
| Summary Date | March 8, 2011 |

### 2. Device Name

| Proprietary name: | GENOSS Collagen Membrane |
|----------------------|---------------------------------------------------|
| Common name: | Resorbable dental barrier membrane, animal source |
| Classification name: | Barrier, animal source, dental |

#### 3. Predicated Device

RCM6 membrane (K003339) Fortgen Oral Membrane (K071555) OSSIX Plus (K053260)

### 4. Description

GENOSS Collagen Membrane is a resorbable membrane to aid the regenerative healing of bone or bone/periodontal ligament defects of the oral cavity.

GENOSS Collagen Membrane is designed to be a passive barrier which excludes epithelial and gingival connective tissue from the defect site so that only the desirable cells repopulate the space, allowing regeneration to occur. Its resorbability eliminates the need for a second surgery.

GENOSS Collagen Membrane is made from bovine tendon, the Type 1 collagen and is sterilized in gamma-radiation.

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# GENOSS

| Model name | Size | | |
|------------|------------|-------------|----------------|
| | Width (mm) | Length (mm) | Thickness (mm) |
| GCM1020 | 10 | 20 | |
| GCM1515 | 15 | 15 | |
| GCM1520 | 15 | 20 | |
| GCM2030 | 20 | 30 | 0.3 |
| GCM2530 | 25 | 30 | |
| GCM3040 | 30 | 40 | |

## 5. Indication for use

GENOSS Collagen Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane into bony defects surrounding teeth and on alveolar ridges.

- Periodontal/infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Guided bone regeneration (GBR) procedures
- Sinus lifts

# 6. Technological Characteristics

GENOSS Collagen membrane has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of GENOSS Collagen membrane, RCM6 membrane, FORTAGEN ORAL membrane, OSSIX -PLUS are as following

| GENOSS Collagen Membrane | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | GENOSS Collagen Membrane is intended to be used during guided bone and<br>guided tissue regeneration procedures as a biodegradable barrier membrane into<br>bony defects surrounding teeth and on alveolar ridges.<br>- Periodontal/infrabony defects<br>- Ridge augmentation<br>- Extraction sites (implant preparation/placement)<br>- Guided bone regeneration (GBR) procedures<br>- Sinus lifts |
| | Material |

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K102307

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| Children and country and consider of the consisted<br>Crosslinking | Carbodiimide (EDC) |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Gamma Irradiation<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

| RCM6 membrane | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | RESORBABLE COLLAGEN MEMBRANE is intended for use in oral surgical<br>procedures as a resorbable material for placement to aid in wound healing in the<br>areas of dental implants, bone defects, periodontal defects and ridge<br>augmentation.<br>- Ridge Augmentation<br>- Bone Regeneration around Implants<br>- Sinus Window<br>- Extraction Sites<br>- Periodontal Defects |
| Material | Type I bovine collagen |
| Crosslinking | Formaldehyde (FA) |
| Sterilization | Gamma Irradiation |

| FORTAGEN ORAL MEMBRANE | |
|------------------------|--------------------------------------------------------------------------------|
| Indication for use | FortaGen Oral Membrane is intended to be used during guided bone and guided |
| | tissue regeneration procedures as a biodegradable barrier membrane for: |
| | - Ridge augmentation for later implant insertions; |
| | - Simultaneous ridge augmentation and implant insertions; |
| | - Ridge augmentation around implants inserted in delayed extraction sites; |
| | - Ridge augmentation around implants inserted in immediate extraction sites; |
| | - Alveolar ridge preservation consequent to tooth (teeth) extraction(s); |
| | - Over the window in lateral window sinus elevation procedures; |
| | - In implants with vertical bone loss due to infection, |
| | - In implants with vertical bone loss due to infection, only in cases where |
| | satisfactory debridement and implant surface disinfection can be achieved; |
| | - In intra bony defects around teeth |
| | - For treatment of recession defects, together with coronally positioned flap; |
| | - In furcation defects in multi-rooted teeth. |

.

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102307

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| Material | Type I porcine collagen |
|---------------|-------------------------|
| Crosslinking | Carbodiimide (EDC) |
| Sterilization | Gamma Irradiation |

| OSSIX -PLUS | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | OssixHt-PLUS biodegradable collagen membrane is intended for use during the<br>process of guided bone regeneration (GBR) and guided tissue<br>regeneration (GTR) as a biodegradable barrier for:<br>- Ridge augmentation for later implant insertions.<br>- Simultaneous ridge augmentation and implant insertions.<br>- Ridge augmentation around implants inserted in delayed extraction sites.<br>- Ridge augmentation around implants inserted in immediate extraction sites.<br>- Alveolar ridge preservation consequent to tooth (teeth) extraction(s).<br>- Over the window in lateral window sinus elevation procedures.<br>- In implants with vertical bone loss due to infection, only in cases where<br>satisfactory debridment and implant surface disinfection can be achieved.<br>- In intra bony defects around teeth.<br>- For treatment of recession defects, together with coronally positioned flap<br>- In furcation defects in multi rooted teeth. |
| | Material |
| | Crosslinking |
| | Sterilization |

### 7. Performance Data

Biocompatibility testing on the proposed GENOSS Collagen Membrane has been completed. Requirements for biological evaluation of the proposed device were based on the Blue Book Memorandum G95-1 issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part I: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:

-ISO Cytotoxicity

-ISO Systemic toxicity

-ISO Pyrogencity -ISO Sensitization

510(k) Summary: K102307

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102307

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-ISO Intracutaneous reactivity -ISO Implantation -ISO Genotoxicity(Ames)

-ISO Genotoxicity(Micro-nucleus) -ISO Haemocompatibility -ISO Elution assay

-ISO Genotoxicity(Sister chromatid)

The proposed GENOSS Collagen Membrane was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics:

-Shrink temperature (DSC) -Tensile strength

-Decomposition time -Swelling

Also, raw material was evaluated in accordance with ASTM F2212-08 to confirm the safety of collagen raw material:

| -Virus inactivation | -Amino acid analysis |
|---------------------|----------------------|
| -Endotoxin | -SDS-PAGE |

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the GENOSS Collagen Membrane met the established specifications necessary for consistent performance according to its intended use.

## 8. Conclusion

Based on the information provided in this premarket notification GENOSS Co., Ltd. concludes that GENOSS Collagen Membrane is substantially equivalent to predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Genoss Company, Limited C/O Dr. Eunkyung Son Dentium USA 11075 Knott Avenue, Suite A Cypress, California 90630

- 4 2011 MAY

Re: K102307

Trade/Device Name: GENOSS Collagen Membrane Regulation Number: 21 CFR 872,3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: April 26, 2011 Received: May 2, 2011

Dear Dr. Son:

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.

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Page 2- Dr. Son

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/ucm 115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ph for

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

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GENOSS

# Indication for use

510(k) Number:

长102307

Device Name:

GENOSS Collagen Membrane

Indication for use:

GENOSS Collagen Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane into bony defects surrounding teeth and on alveolar ridges.

- Periodontal/infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Guided bone regeneration (GBR) procedures
- Sinus lifts

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Indication for use

510(k) Number:

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