BONGROS HA

K090793 · Bioalpha, Inc. · LYC · May 19, 2009 · Dental

Device Facts

• Record ID: K090793
• Device Name: BONGROS HA
• Applicant: Bioalpha, Inc.
• Product Code: LYC · Dental
• Decision Date: May 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bongros®-HA (HAGS, HAGM, HAGL) is intended for use in dental surgery. The products may be used in surgical procedures such as: · Augmentation or reconstructive treatment of the alveolar ridge · Filling of extraction sockets to enhance preservation of the alveolar ridge · Elevation of the maxillary sinus floor · Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.

Device Story

Bongros®-HA is a synthetic bone grafting material composed of highly pure hydroxyapatite (Ca10(PO4)6(OH)2). It features a trabecular, 3D interconnected pore structure mimicking human cancellous bone. Used in dental surgery by clinicians, the material is placed in direct contact with viable bone; it acts as a scaffold where hard tissue infiltrates the reticulated spaces. Bone formation occurs in apposition to the surface and within the interstices of the implant skeleton. The device is provided sterile for single use and is available in three size models (HAGS, HAGM, HAGL). It aids in alveolar ridge preservation, sinus floor elevation, and defect filling, facilitating bone regeneration in dental procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Synthetic hydroxyapatite (Ca10(PO4)6(OH)2); trabecular 3D interconnected pore structure; sterile, single-use; available in three sizes (HAGS, HAGM, HAGL).

Indications for Use

Indicated for dental surgery patients requiring alveolar ridge augmentation/reconstruction, extraction socket filling for ridge preservation, maxillary sinus floor elevation, or filling of peri-implant defects in conjunction with guided bone regeneration 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

• Osteograf (K981182)
• EndoBon (K980679)
• SynOss (K072397)
• Bio-Oss (K952619)

Submission Summary (Full Text)

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# 510(k) SUMMARY

MAY 19 2009

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## Submitter:

| Name: | BioAlpha Inc. |
|----------|--------------------------------------------------------------------------|
| Address: | 223-23 Sangdaewon-Dong, Jungwon-Gu, Seongnam, Gyeonggi Do, 462-120 Korea |

### US Agent:

| Name: | Alex Chang |
|------------|-------------------------------------------------------------|
| Address: | Bionet America Inc. 2691 Dow Ave. Suite B, Tustin, CA 92780 |
| Phone No.: | 714-838-1274, 949-468-6312 |
| Fax No.: | 714-734-1761 |
| E-Mail: | [e-mail] |

## Official Correspondent:

| Name: | Hyun-Seung Ryu, Ph.D |
|------------|-----------------------------------------------------------------------------|
| Address: | 223-23 Sangdaewon-Dong, Jungwon-Gu, Seongnam, Gyeonggi<br>Do, 462-120 Korea |
| Phone No.: | [phone] |
| Fax No.: | [phone] |
| E-Mail: | [e-mail] |

### Device Identification

| Proprietary Name: | Bongros®-HA |
|----------------------|----------------------------------------------|
| Common/Usual Name: | Bone grafting material |
| Classification Name: | Bone Grafting Material, Synthetic , 872.3930 |
| Product Code: | LYC |
| Review Panel: | Dental |

### Substantially Equivalent Predicate Legally Marketed Devices

The subject device is deemed to be substantially equivalent to those following devices manufactured and currently available in commercial distribution.

| Device Name | Osteograf | EndoBon | SynOss | Bio-Oss |
|---------------|-----------|---------|---------|---------|
| 510(k) Number | K981182 | K980679 | K072397 | K952619 |
| Decision | SE | SE | SE | SE |
| Product Code | LYC | LYC | LYC | LYC |

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#### Device Description

Bongros®-HA is made of highly pure, synthetic hydroxyapatite (Ca10(PO4)6(OH)2). Bongros®-HA has trabecular structure that resembles the 3-dimensional interconnected pore structure of human cancellous bone. When Bongros -HA is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with hard tissue. Bone formation occurs in apposition to the Bongros® HA surface and within the interstices of the implant skeleton.

Bongros -HA have three specific models which are HAGS, HAGM and HAGL. The quality of the material of HAGS, HAGM and HAGL is equal but only the sizes of each model are different from each other.

Therewith, Bongros®-HA is provided sterile for single use.

#### Indications for Use

Bongros -HA (HAGS, HAGM, HAGL) is intended for use in dental surgery.

The products may be used in surgical procedures such as:

- · Augmentation or reconstructive treatment of the alveolar ridge
- · Filling of extraction sockets to enhance preservation of the alveolar ridge
- · Elevation of the maxillary sinus floor
- · Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.

## Technological Characteristics and Substantial Equivalence

Bongros®-HA is substantially equivalent to predicate devices. Bongros®-HA and predicate devices are identical in intended use, indication and application. Therewith, Bongros -HA and predicate devices are biocompatible and have similar properties.

Based on the discussion above, BioAlpha Inc. believes that Bongros® HA is substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling three overlapping human figures or ribbons, positioned to the right. To the left of the symbol is a circular seal containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Public Health Service

19 2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hyun-Seung Ryu, Ph.D Director BioAlpha, Incorporated 223-23 Sangdaewon-Dong, Jungwon-Gu Seongnam, Gyeonggi-Do 462-120 KOREA

Re: K090793

Trade/Device Name: Bongros -HA Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: March 19, 2009 Received: March 24, 2009

Dear Dr. Ryu:

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.

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.

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.

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Page 2- Dr. Ryu

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Rummer

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K090793 Device Name: Bongros -HA

Indications for Use:

Bongros®-HA (HAGS, HAGM, HAGL) is intended for use in dental surgery.

The products may be used in surgical procedures such as:

· Augmentation or reconstructive treatment of the alveolar ridge

· Filling of extraction sockets to enhance preservation of the alveolar ridge

· Elevation of the maxillary sinus floor

· Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.

Rin Maly for MSR

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090793

Prescription Use X (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)