(83 days)
Not Found
Not Found
No
The description focuses on the material composition and physical properties of the bone grafting material, with no mention of AI or ML.
Yes
The device is described as a bone grafting material intended to fill, augment, or reconstruct periodontal or bony defects, which is a therapeutic function.
No
The device description indicates that Bond Bone™ is a bone grafting material intended to fill, augment, or reconstruct defects. Its use focuses on treatment and repair, not on diagnosing conditions or diseases.
No
The device description clearly states that Bond Bone™ is a physical material (granulated powder) that forms a paste and hardens, indicating it is a hardware/material-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Bond Bone™ Description: Bond Bone™ is a synthetic bone grafting material intended to be implanted directly into the body to fill, augment, or reconstruct bone defects. It is a physical material used for structural support and regeneration, not a test performed on a sample outside the body.
- Intended Use: The intended use describes its application in bone regenerative techniques and as a barrier, all of which are direct interventions within the body.
Therefore, Bond Bone™ falls under the category of a medical device used for surgical or regenerative purposes, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
Bond Bone™ is a synthetic ostcoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
Not Found
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.
Not Found
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
510(k) Summary
Augma Biomaterials, Ltd. Bond Bone™
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Augma Biomaterials, Ltd. 8 Usishkin Street Netanya 42273 Israel Telephone: +972-(0)77-3253128 Fax: +972-(0)9-8335281
Official Contact:
Representative/Consultant:
Dr. Amos Yahav
David J. Collette or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 email: dcollette@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations: Product Code Classification Panel: Reviewing Branch:
Bond Bone™ Bone Grafting Material, Synthetic 21 CFR 872.3930 LYC Dental Products Panel Dental Devices Branch
INTENDED USE
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
MAR 1 7 2009
Bond Bone™
1
510(k) Summary
Bond Bone
2 of 2
DEVICE DESCRIPTION
Bond Bone™ is a synthetic ostcoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
EQUIVALENCE TO MARKETED PRODUCT
Augma Biomaterials, Ltd., demonstrated that, for the purposes of FDA's regulation of medical devices, Bond Bone is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
APR - 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Augma Biomaterials, Limited C/o Mr. David J. Collette PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K083858
Trade/Device Name: Bond Bone™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 23, 2008 Received: December 29, 2008
Dear Mr. Collette:
This letter corrects our substantially equivalent letter of March 12, 2009.
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 (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.
3
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); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0101. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/dsma/dsmamain.html
Sincerely yours,
Susan Runre
Ginette Y. Michaud, M.D. 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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510(k) Premarket Notification
Bond Bone™
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Indications for Use
510(k) Number (if known):
Bond Bone™ Device Name:
Indications for Use:
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
| 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sigi. Off) | |
|---|---|
| Division of An sthesiology, General Hospital | |
| Infection Contiui, Dental Devices |
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| 510(k) Number: | K083858 |
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