(455 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical outcomes of a synthetic bone graft substitute, with no mention of AI or ML technologies.
Yes
The device is described as a bone graft substitute used to fill, augment, or reconstruct periodontal or bony defects, which are therapeutic actions addressing medical conditions.
No
The device description and intended use indicate that Bone Plus™ BCP is a bone graft substitute used for filling, augmenting, or reconstructing bony defects. It is a therapeutic device, not one that gathers information about a patient's condition to help diagnose a disease or injury.
No
The device description clearly states that Bone Plus™ BCP is a synthetic resorbable osteo-conductive bone graft substitute composed of physical materials (Hydroxyapatite and beta-Tricalcium Phosphate) and has a physical structure. It is supplied sterile and is for single use, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that is implanted into the body to fill, augment, or reconstruct bone defects. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a synthetic bone graft substitute, which is a material used in surgical procedures.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or condition. IVDs are used to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
The device described is a medical device used for surgical intervention and tissue regeneration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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 ●
- 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
Product codes (comma separated list FDA assigned to the subject device)
LYC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- . 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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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.
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 ●
1
- 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)
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Division Sign-Off)
vision of Anesthesiology, General Hospital
rection Control, Dental Devices
10(k) Number: K090950