(63 days)
Not Found
No
The summary describes a bone grafting material and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is indicated for "treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting," which are therapeutic applications.
No
Explanation: This device is a bone graft material used for treatment of defects and augmentation, not for diagnosing conditions.
No
The device description clearly states it is a material (polycrystaline hydroxylapatite particles) used for grafting, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used for surgical procedures to treat bone defects and augment bone. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and form of a bone graft material. This is consistent with a surgical implant or material, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The OsteoGraf/N-300 does not fit this description.
N/A
Intended Use / Indications for Use
OsteoGraf/N-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.
Product codes
LYC
Device Description
The OsteoGraf/N-300 material is a natural, high purity, radiopaque, polycrystaline hydroxylapatie, the major mineral phase of bone and dental enamel. It is manufactured as an anorganic, rounded irregular shaped bovine-derived hydroxylapatite particles, sized at 250-420 microns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
OsteoGraf/N-300, K981182, K960348, K902295
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
510(k) SUMMARY
SEP - 4 2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | June 25, 2007 |
| TRADE OR PROPRIETARY NAME: | OsteoGraf/N-300 |
| CLASSIFICATION NAME: | Bone Grafting Material 21 CFR 872.3930 |
| PREDICATE DEVICES: | OsteoGraf/N-300, K981182, K960348, K902295 |
DEVICE DESCRIPTION: The OsteoGraf/N-300 material is a natural, high purity, radiopaque, polycrystaline hydroxylapatie, the major mineral phase of bone and dental enamel. It is manufactured as an anorganic, rounded irregular shaped bovine-derived hydroxylapatite particles, sized at 250-420 microns.
INTENDED USE: Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in OsteoGraf/N-300 have been used in legally marketed devices and/or were found safe for dental use. OsteoGraf/N-300 and the marketed device are biocompatible. OsteoGraf/N-300 conforms to applicable industry standards.
We believe that the prior use of the components of OsteoGraf/N-300 in legally marketed devices. the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/N-300 for the indicated uses.
1
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three overlapping wings.
SEP - 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872
Re: K071817
Trade/Device Name: OsteoGraf/N-300 Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 8, 2007 Received: August 10, 2007
Dear Ms. Lewis:
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 such 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.
2
Page 2 - Ms. Lewis
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 begin 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Russo
. Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
Koni 817 510(k) Number (if known):
Device Name: OsteoGraf/N-300
Indications for Use:
OsteoGraf/N-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.
These are the same indications for use previously cleared for K981182.
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)
Suan Burnes
Jivision Sign-Off) livision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K071
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