(56 days)
Not Found
No
The device description focuses on the material composition and physical structure of a synthetic bone graft material, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a synthetic bone graft material used in dental surgery to augment or reconstruct bone, not to treat or cure a disease.
No
The product description indicates that Bongros®-HA is a synthetic bone graft material used in dental surgical procedures to augment or reconstruct bone, not to diagnose a condition.
No
The device description clearly states that Bongros®-HA is made of synthetic hydroxyapatite and has a physical structure, indicating it is a material-based implant, not software.
Based on the provided information, Bongros®-HA is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that Bongros®-HA is for use in dental surgery for procedures like augmentation, filling sockets, sinus lifts, and filling peri-implant defects. These are all surgical procedures performed directly on the patient's body.
- Device Description: The description details a synthetic hydroxyapatite material with a structure resembling bone, intended to be placed in contact with viable bone for tissue infiltration and bone formation. This is a material implanted into the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Bongros®-HA does not interact with or analyze such specimens. It is a material used for surgical reconstruction.
Therefore, Bongros®-HA is a medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended 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.
Product codes
LYC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, maxillary sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K981182, K980679, K072397, K952619
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'K090793'. The characters are written in a cursive style, with some connections between the letters and numbers. The image is in black and white, and the characters are clearly visible against the background.
510(k) SUMMARY
MAY 19 2009
【
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: | achang@bionetus.com |
Official Correspondent:
| Name: | Hyun-Seung Ryu, Ph.D |
|---|---|
| Address: | 223-23 Sangdaewon-Dong, Jungwon-Gu, Seongnam, Gyeonggi |
| Do, 462-120 Korea | |
| Phone No.: | +82-31-746-5209 |
| Fax No.: | +82-31-749-5208 |
| E-Mail: | hsryu@daewoong.co.kr |
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 |
1
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
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)