(63 days)
Unigraft®, PerioGlas®, BioGran®
Not Found
No
The summary describes a synthetic bioactive glass material for bone repair and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
The device is intended to fill and/or augment dental and oral/maxillofacial defects, which constitutes a therapeutic action.
No
The device description states it is a synthetic bioactive glass intended for repair, filling, and augmentation of defects, not for diagnosis.
No
The device description explicitly states that Ossiform is a "synthetic bioactive glass granules" supplied in a "polyolefin vial within a sealed pouch," indicating it is a physical material, 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 states that Ossiform is intended to fill and/or augment dental and oral/maxillofacial defects. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a synthetic bioactive glass used for repair, again indicating a therapeutic function.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to examine specimens from the human body for diagnostic purposes. Ossiform is used in vivo (inside the body) for repair and augmentation.
N/A
Intended Use / Indications for Use
Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, sinus lifts, cystic defects, extraction sites, craniofacial augmentation and augmentation of the alveolar ridge.
Product codes
LYC
Device Description
Ossiform is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral/maxillofacial, dental intraosseous
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)
The performance of Ossiform was evaluated using a variety of test methods. The results of these tests demonstrate that Ossiform is substantially equivalent to a predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Unigraft®, PerioGlas®, BioGran®
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.
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510(k) summary
(As Required by Section 807.92 (c))
- Unicare Biomedical, Inc. 1. Name: 25951 La Cuesta Avenue, Laguna Hills, CA 92653 Address: Stan Yang, 949-643-6707 Contact: February 28, 2002 Date:
- Ossiform 2. Trade Name: Synthetic bone graft material Common Name: Endosseous implant for bone filling and augmentation Classification Name: Unclassified Device Classification:
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- Device Description
Ossiform is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.
4. Predicate Devices
The Ossiform device is substantially equivalent to devices currently in US commercial distribution, which are classified as endosseous implant for bone filling and augmentation. Examples of such products include Unigraft®, PerioGlas® and BioGran®. These products are made of bioactive ceramic materials with similar performance.
5. Intended Use
Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, ridge augmentation, extraction sites, cranio-facial augmentation, sinus lifts and cystic defects
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- Device Testing
The performance of Ossiform was evaluated using a variety of test methods. The results of these tests demonstrate that Ossiform is substantially equivalent to a predicate device.
- Device Testing
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as flowing, abstract shapes. The figures are stacked on top of each other, creating a sense of unity and support.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 7 2002
Mr. Stan Yang Vice President Unicare BioMedical, Incorporated 25951 La Cuesta Avenue Laguna Hills, California 92653
Re: K020720
Trade/Device Name: OSSIFORM Regulation Number: None Regulation Name: Endosseous Implant Regulatory Class: Unclassified Product Code: LYC Dated: March 1, 2002 Received: March 5, 2002
Dear Mr. Yang:
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.
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K020720
510(K) NUMBER: DEVICE NAME: OSSIFORM INDICATIONS FOR USE:
Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, sinus lifts, cystic defects, extraction sites, craniofacial augmentation and augmentation of the alveolar ridge.
Concurrence of CDRH, Office of device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Gunner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________