Augmentation or reconstructive treatment of alveolar ridge .
. Filling of periodontal defects
Filling of defects after root resection, apicocectomy, and cystectomy .
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

Device Description

Bone Plus™ BCP is a synthetic resorbable osteo-conductive bone graft substitute composed of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (beta-TCP). Bone Plus™ BCP presents a interconnected porosity structure, similar to that of human cancellous bone. It is supplied sterile and it is dedicated for single use.

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study information for the Bone Plus™ BCP device, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed scientific paper on a clinical trial. Therefore, much of the information typically found in a study proving device performance (like specific statistical metrics, detailed ground truth establishment for a test set, expert qualifications, or MRMC studies) is not present. The purpose of a 510(k) summary is to demonstrate equivalence to a predicate device, often through non-clinical testing and comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Summary)
Material Composition	60% HA and 40% Beta-TCP (similar to predicates)	Comprised of 60% Hydroxyapatite (HA) and 40% Beta Tricalcium Phosphate (β-TCP)
Physical Characteristics	Interconnected porosity similar to human cancellous bone	Presents an interconnected porosity structure, similar to that of human cancellous bone
Sterility	Sterile	Supplied sterile
Single Use	Dedicated for single use	Dedicated for single use
Biocompatibility	No adverse tissue reactions (implied by predicate history)	(Not explicitly detailed, relies on substantial equivalence to predicates)
Resorbability	Resorbable (implied by predicate function)	Synthetic resorbable osteo-conductive bone graft substitute
Functionality/Performance	Fill, augment, or reconstruct periodontal/bony defects as intended. Must perform comparably to predicate devices in: - Histomorphometric Evaluation - Chemical and Physical Analysis - Porosity assessment - Solubility	"Testing and other comparisons have established that the subject of Bone Plus™ BCP substantially equivalent in design, materials, indications and intended use, and performance to other predicate devices of the type currently marketed in the U.S." Studies performed: - Histomorphometric Evaluation of Bone Plus™ BCP - Chemical and Physical Analysis of Bone Plus™ BCP - Porosity assessment of Bone Plus™ BCP - Solubility Test of Bone Plus™ BCP - Clinical Study of Bone Plus™ BCP

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions a "Clinical Study of Bone Plus™ BCP" but does not provide details on its sample size, methodology, or results. Given the context of a 510(k), this study was likely supportive evidence for substantial equivalence rather than a full-scale clinical trial with a defined test set for performance metrics.
Data Provenance: Not specified for the "Clinical Study." The manufacturer is MegaGen Implant Co., Ltd. from South Korea, so it's possible the clinical data originated there, but this is not confirmed. It's also not specified if it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not specified. The 510(k) summary does not provide details on how "ground truth" was established for any clinical or performance studies, nor does it mention the involvement of experts in that capacity.

4. Adjudication Method for the Test Set

Not specified. No information is provided regarding adjudication methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or implied. The document focuses on demonstrating substantial equivalence to predicate devices through various technical and likely non-clinical evaluations, along with a mention of a "Clinical Study," the details of which are not provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a bone grafting material, not a software algorithm or AI-powered diagnostic tool. Performance is assessed through material properties, biological interaction, and clinical outcomes, not an "algorithm-only" evaluation.

7. The Type of Ground Truth Used

For the technical and material characterization studies (histomorphometric, chemical, physical, porosity, solubility), the "ground truth" would be established by standard analytical methodologies, laboratory measurements, and histological examination by qualified personnel (e.g., histologists, materials scientists).
For the "Clinical Study," the nature of the ground truth is not specified, but it would typically involve clinical assessments, radiographic evidence, and potentially histological analysis of biopsies from the implantation sites, interpreted by clinicians or pathologists. The document implies comparison to clinical outcomes of the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical implant (bone graft material), not a machine learning model or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this type of device.

Summary

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K090950

JUL--2 2010

ﻟﻤﺴﺎ ﺍﻟﻤﺴﺎﻓﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

510(K) Summary

Submitter MegaGen Implant Co., Ltd. Seung Kyu Park 377-2 Gyochon-Ri, Jain-Myeon, Gyeongsan-Si, Gyeongbuk, South Korea Phone: 82-53-857-5770 Fax: 82-53-857-5432

Official Correspondent Kodent Inc. Eugene Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: kodentinc@kodent.co.kr Phone: 562-404-8466 Fax: 562-404-2757

Device Information

Trade name: Bone Plus™ BCP

Common name: Bone grafting material

Classification name: Bone Grafting Material, Synthetic

Classification product code: LYC

Regulation number: 872.3930

Device class: Class II

Device Description

Indication for Use

Bone Plus™ BCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Augmentation or reconstructive treatment of alveolar ridge .
. Filling of periodontal defects
Filling of defects after root resection, apicocectomy, and cystectomy .
Filling of extraction sockets to enhance preservation of the alveolar ridge .
Elevation of maxillary sinus floor ●

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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

Device Type

Bone Plus™ BCP Needle Graft. .

Materials

Bone Plus™ BCP is comprised of 60% Hydroxyapatite (HA) and 40% Beta Tricalcium Phosphate (f9-TCP)

Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

MBCP™ (K051885) manufactured by Biomatlante Co., Ltd. .
Cerasorb® Dental (K051443) manufactured by Curasan AG .
Bio-Oss Collagen (K974399) manufactured by Geistlich-Pharma .

Comparison to Predicate Devices

Testing and other comparisons have established that the subject of Bone Plus™ BCP substantially equivalent in design, materials, indications and intended use, and performance to other predicate devices of the type currently marketed in the U.S.

. Histomorphometric Evaluation of Bone Plus™ BCP
Chemical and Physical Analysis of Bone PlusTM BCP .
Porosity assessment of Bone Plus™ BCP ●
Solubility Test of Bone Plus™ BCP .
Clinical Study of Bone Plus™ BCP .

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

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

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

JUL - 2 2010

Re: K090950

Trade/Device Name: Bone Plus BCP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 20, 2010 Received: June 22, 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.

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. 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 (800) 638-2041 or (301) 796-7100 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): K090950

Device Name: Bone Plus™ BCP

Indication for Use:

Bone Plus™ BCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Augmentation or reconstructive treatment of alveolar ridge .
Filling of periodontal defects .
Filling of defects after root resection, apicocectomy, 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

Prescription Use ________x

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Page 1 of 1

Division Sign-Off)

vision of Anesthesiology, General Hospital

rection Control, Dental Devices

10(k) Number: K090950

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.