POLYBONE DENTAL

K092194 · Kyung Won Medical Co., Ltd. · LYC · Jun 16, 2010 · Dental

Device Facts

• Record ID: K092194
• Device Name: POLYBONE DENTAL
• Applicant: Kyung Won Medical Co., Ltd.
• Product Code: LYC · Dental
• Decision Date: Jun 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.

Device Story

PolyBone® Dental is a synthetic, resorbable bone graft substitute composed of 100% beta-tricalcium phosphate. It functions as an osteoconductive scaffold to support bone formation. The material features multidirectional interconnected porosity (75-85%) with pore sizes of 200-500 µm. Bone regeneration occurs as bone cells resorb dicalcium phosphate dihydrate (brushite), a conversion product of the beta-tricalcium phosphate. The device is intended for use by clinicians to fill or reconstruct bony defects in the oral and maxillofacial region, serving as a substitute for autogenous or allogenic bone grafts. It is replaced by natural bone during the healing process.

Clinical Evidence

No clinical data provided. Biocompatibility testing was performed according to ISO 10993-1:2003, including cytotoxicity, sensitization, irritation, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, and implantation, demonstrating the device is biologically safe.

Technological Characteristics

Synthetic resorbable bone graft material; 100% beta-tricalcium phosphate; porous scaffold; 75-85% porosity; 200-500 µm pore size; biocompatibility tested per ISO 10993-1:2003.

Indications for Use

Indicated for patients requiring filling, augmentation, or reconstruction of periodontal or bony defects in the oral and maxillofacial region, including alveolar ridge augmentation, sinus lifts, and treatment of intraosseous defects.

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

• OSSAPLASTTM DENTAL (K053374)
• Cerasorb® M Dental (K051443)

Submission Summary (Full Text)

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Kyungwon Medical Co., Ltd.

Confidential

#### 510(k) Summary

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

06/04/10 Date: _

- 1. Company making the submission

| | Submitter |
|---------|--------------------------------------------------------------------------------------------------|
| Name | Kyungwon Medical Co.,Ltd |
| Address | Suite 601 World Meridian Venture Center, 60-24<br>Gasan-Dong, Geumcheon-Gu, Seoul, Korea 153-801 |
| Phone | [phone]~8 |
| Fax | [phone] |
| Contact | Ju Yun |
| Website | http://www.kyungwonmedical.com |

- 2. U.S Agent/Contact Person
13340 E Firestone Blvd. Suite J, Santa Fe Springs, CA 90670 Joyce Bang Phone: [phone] Fax: [phone] Email : [e-mail]

- 3. Device
Trade Name: PolyBone® Dental Common Name: Bone Grafting Material Classification Name: Bone Grafting Material, Synthetic Classification regulation: 21CFR872.3930

- 2. Predicate Device:
OSSAPLASTTM DENTAL(K053374) / Cerasorb® M Dental(K051443)

- 3. Description:
PolyBone® Dental is a synthetic resorbable calcium phosphate bone grafting material which consists of 100% beta-tricalcium phosphate.

It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 75~85% with a 200~500 um pore size.

Mechanism of PolyBone Dental's bone regeneration works by bone cells resorbing dicalciumphosphate dihydrate (DCPD, brushite), which is a conversion material of ß tricalcium phosphate.

510(k) Submission. .

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Confidential

#### 4. Indication for use:

PolyBone® Dnetal is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.

- 5. Review:
PolyBone® Dental has the similar technological characteristics to the predicate devices: components, indication for use, chemical and performance properties.

Components Similarities All devices are packed in containers.

Indication for Use Similarities All devices have the same indication for use.

#### Chemical Similarities

All devices are made up from 3-Tricalcium phosphate family.

#### Performance Properties Similarities

All devices are for filling, augmenting, or reconstructing periodontal or bony defects or the oral, maxillofacial region.

#### Biocompatibility

The biocompatibility test of PolyBone® Dental has been performed based on ISO10993-1:2003: cvtotoxicity, sensitization, irritation, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity and implantation. The testing results show PolyBone® Dental to be biologically safe.

- 6. Conclusion
Based on the information provided in this premarket notification, Kyungwon Medical Co.,Ltd. concludes that PolyBone® Dental is safe, effective and substantially equivalent to the predicate devices as described herein.

510(k) Submission.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle in flight, with three curved lines representing the wings and body of the eagle. Below the eagle is a wavy line, which may represent water or land. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.

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

Kyungwon Medical Company, Limited C/O Ms. Joyce Bang Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K092194

Trade/Device Name: Polybone® Dental Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 4, 2010 Received: June 7, 2010

Dear Ms. Bang:

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.

JUN 1 32010

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- Ms. Joyce Bang

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.htm.

Sincerely yours.

Nh 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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# Indication for Use

510(k) Number (if known)

K092194

## Device Name: PolyBone® Dental

### Indications for Use:

PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.

AND/OR Over-The-Counter Use x Prescription Use (21CRF 801 Subpart C) (21CRF 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices 510(k) Number:

510(k) Submission.

Indication for Use , 1 / 1 page