OCS-B

K113246 · Nibec Company, Limited · NPM · Jan 16, 2013 · Dental

Device Facts

• Record ID: K113246
• Device Name: OCS-B
• Applicant: Nibec Company, Limited
• Product Code: NPM · Dental
• Decision Date: Jan 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K113246 · Jan 16, 2013	OCS-B	Nibec Company, Limited	Clinical case series (patient medical records/clinical practice)	A clinical case series of seven patients was used to demonstrate defect healing and new bone formation following the use of OCS-B™ in periodontal defects.	Clinical case series; Periodontal defects; Histological evaluation; Radiographic assessment

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical case series of OCS-B™; Case series	Patients with intrabony periodontal defects; Sample Size: 7	Not applicable for this study	Defect healing and formation of new bone

Indications for Use

OCS-BTM cancellous and cortical granules are recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - - Filling of defects after root resection; apicoectorny, and cystectorny - - Filling of extraction sockets to enhance preservation of the alveolar ridge - - -Elevation of maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue । Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Device Story

OCS-B™ is a sterile, porous, anorganic bovine-derived hydroxyapatite bone mineral matrix. Supplied as cancellous or cortical granules in single-use containers; sterilized via gamma irradiation. Used by dental clinicians in oral/periodontal surgical procedures to facilitate osteoconduction and new bone formation. The material acts as a scaffold for osteoblasts; it is resorbed over time as new bone replaces the graft. Clinical application involves placing granules into bony defects, often in conjunction with GTR/GBR membranes, to restore bone volume for subsequent dental implant placement. Benefits include preservation of alveolar ridge and structural support for bone regeneration.

Clinical Evidence

Evidence includes biocompatibility testing per ISO 10993 (genotoxicity, reactivity, sensitization, pyrogenicity, toxicity, cytotoxicity, implantation) and a clinical case series of seven patients with intrabony periodontal defects. Clinical data included baseline and follow-up radiographs and histological evaluation via core biopsy, demonstrating new bone growth and sufficient quality for dental implant placement. Animal studies confirmed bone formation and resorption rates comparable to the predicate.

Technological Characteristics

Anorganic bovine-derived hydroxyapatite bone mineral matrix. Porous structure with interconnecting macro and micro pores. Supplied as cancellous or cortical granules. Sterilized by gamma irradiation (SAL 10^-9). Non-pyrogenic. Shelf life of 3 years.

Indications for Use

Indicated for human oral and periodontal bone grafting, including alveolar ridge augmentation, filling of infrabony periodontal defects, root resection/apicoectomy/cystectomy defects, extraction sockets, maxillary sinus floor elevation, and peri-implant defects in conjunction with GTR/GBR products.

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

• Bio-Oss® bone grafting material (K871773, K952617, K970321, K033815)

Submission Summary (Full Text)

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# 510(k) Summary

[as required by 807.92(c)]

# Sponsor/Applicant

NIBEC Co., Ltd.

lwol electricity-electronic Agro-industrial Complex, 1127, Sinwol-ri,

lwol-myeon, Jincheon-gun, Chungcheongbuk-do, Korea

Phone : [phone]

Fax : [phone]

Contact : Dr. Park, Yoon-Jeong

Date Prepared : JANUARY 07, 2013

# Device Name and Identification

Proprietary Name : OCS-B™

Common / Usual Name : Bone Mineral Matrix

Anorganic Bovine Bone Grafting Material

Classification Name :

Bone Grafting Material

Animal Source Dental Bone Grafting Material

#### Predicate Device

Bio-Oss® bone grafting material (K871773, K952617, K970321, K033815)

Manufactured by :

Geistlich Pharma AG

Bahnhofstrasse 40

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#### CH-6110 Wolhusen

Switzerland

# Device Category/Class

Device Class : Class II

Regulation Number : 21 C.F.R. 872.3930

Product Code : NPM

### Indication for use

OCS-BT® cancellous and cortical granules are recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects. -
- Filling of defects after root resection; apicoectorny, and cystectorny -
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- -Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue । Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

#### Device Description

-

OCS-B™ is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.

#### Basis for Substantial Equivalence

OCS-B™ and Bio-Oss® have a similar physical and chemical structure. Both are porous, biocompatible bone grafts that facilitate the formation and mineralization of new bone by the

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osteoblast. As both products have same source of bone (bovine source) and similar process for removal of organic compounds, the product is substantially equivalent to Bio-Oss®

The following table summarizes the basis for the Sponsor's substantial equivalence determination :

# Table 1 Substantial Equivalence Comparison

| ITEM | OCS-BTM | Bio-Oss® |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended Use | Used as an adjective therapy in restoring bony defects | Used as an adjective therapy in restoring bony defects |
| Target population | Human Oral, Periodontal | Human Oral, Periodontal |
| Dosage form | Granules contained in single use container | Granules contained in single use container |
| Granule sizes | 0.2mm to 1.0mm or 1.0mm to 2.0 mm granules | 0.25mm to 1.0mm or 1.0mm to 2.0 mm granules |
| Material | Anorganic derived osteoconductive hydroxyapatite bone mineral | Anorganic derived osteoconductive hydroxyapatite bone mineral |
| Source bone | Bovine bone | Bovine bone |
| Physical<br>Morphology | Trabecular, interconnecting macro and micro pores | Trabecular, interconnecting macro and micro pores |
| Biocompatibility | Biocompatible, as demonstrated by :<br>- Genotoxicity testing ( <i>In vitro, In vivo</i> )<br>- Intracutaneous reactivity testing<br>- Maximization and sensitization testing<br>- Pyrogen testing<br>- Acute systemic toxicity testing<br>- Cytotoxicity testing<br>- Implantation testing<br>- Preclinical safety and efficacy testing<br>- Clinical case studies | Biocompatible (as demonstrated in published literature) |
| Performance | Bone formation | Bone formation |
| Compatibility<br>w/other devices | Can be used with GTR membrane | Can be used with GTR membrane |
| Sterilization<br>Process | Sterile by Gamma irradiation | Sterile by Gamma irradiation |
| Chemical<br>Composition | Similar to Bio-Oss® based on<br>chemical analysis, XRD, FT-IR and<br>ICP analysis | Similar to OCS-BTM based on<br>chemical analysis, XRD, FT-IR and<br>ICP analysis |
| Anatomical sites | Oral, Periodontal | Oral, Periodontal |
| Non-pyrogenic | Yes | Yes |
| Shelf life | 3 years | Determined by Manufacturer |
| Risk | Non-risk, as demonstrated by : | |
| | - TSE inactivation Process Validation | |
| | - Virus Clearance study | |
| | - Analysis of residual solvent | |
| | - Risk analysis | |
| | - Cleaning Validation | |

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# Brief Summary of Data Submitted

The Sponsor evaluated the performance characteristics of OCS-B™ and Bio-Oss® with a thorough chemical and physical characterization. The physical and chemical characteristics of the products were found to be comparable. Further, in several animal studies, both products were found to grow new bone and be subsequently resorbed at similar rates. Finally, in a clinical case series, use of OCS-BTM resulted in defect healing and formation of new bone of sufficient quality to obtain dental implant placement. The submission includes a summary of seven individual case studies of OCS-BTM. The patients were treated for intrabony periodontal defects. For each case study, the report includes baseline radiographs, radiographs at various time point, and core biopsy for histological evaluation. Histological and radiographic images demonstrate new bone growth.

OCS-B™ was the subject of the full range of biocompatibility tests recommended in the FDA's "Class II . Special Controls Guidance Document : Dental Bone Grafting Devices" and in accordance with ISO 10993. Organic material has been removed from the product, and product specifications have been established to limit protein content. Throughout the risk analysis for each production step, for example, cleaning validation, the removal of organic solvent, the risk control was conducted during the manufacturing process. In addition, the

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TSE inactivation validation as well as virus inactivation study result was conducted. Further, the product is sterilized to achieve a sterility assurance level SAL 1 x 10-9

Based on the information presented herein, it has been demonstrated that OCS-BM is substantially equivalent to Bio-Oss®.

## Conclusion

The OCS-B™ presents the same types of potential risks to consumers as the predicate device Bio-Oss®, and has controlled these risks in a similar manner. And biocompatibility tests and compatibility test show that the device meets the requirements of those standards. Literatures and post market experience show that the device is substantially equivalent. Comparison with the predicate device shows that the device has similar specification and performance.

Therefore, it is concluded that OCS-B™ are substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 16, 2013

Nibec Company, Limited C/O Mr. Daniel Nam General Manager Pats Corporation 4568 West 181 Street, Suite 104 LOS ANGELES CA 90004

Re: K113246

Trade/Device Name: OCS-BTM Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: January 7, 2013 Received: January 14, 2013

Dear Mr. Nam:

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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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm1.

Sincerely vours.

**Kwame O. Ulmer**

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K (13246

Device Name: OCS-B™

Indications for Use:

OCS-BTM cancellous and cortical granules are recommended for:

Augmentation or reconstructive treatment of the alveolar ridge. -

- Filling of infrabony periodontal defects. -
- Filling of defects after root resection, apicoectorny, and cystectorny -
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue . Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

| Prescription Use | X | AND/OR |
|----------------------|------------------------|--------|
| Subpart D) | (21 CFR 801 Subpart C) | |
| Over-The-Counter Use | (Part 21 CFR 801 | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

| Susan Runner DDS, MA | 2013.01.15 |
|----------------------|------------------|
| | 15:02:04 -05'00' |

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices510(k) Number;