(80 days)
PerioGlas®, BioGran®
BioGran®, PerioGlas®
No
The device description focuses on the material properties and biological interactions of a synthetic bioactive glass, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "a synthetic bioactive glass material for use in the repair of oral defects," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device description clearly states "Unigraft is a synthetic bioactive glass material for use in the repair of oral defects." It describes a material that helps regenerate tissue, not one that identifies or analyzes a condition.
No
The device description clearly states that Unigraft is a "synthetic bioactive glass material" manufactured as "irregular shaped synthetic granules." This indicates a physical material, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The description clearly states that Unigraft is a synthetic bioactive glass material intended for implantation into the body to repair oral defects. It acts as a scaffold for bone regeneration within the body.
- Intended Use: The intended use is for the repair of periodontal defects, extraction sites, and augmentation of the alveolar ridge, all of which are procedures performed in vivo (within the living body).
The device is a medical device used for surgical implantation and tissue repair, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge
Product codes
LYC
Device Description
Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.
The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral defects, periodontal infrabony defects, extraction site, alveolar ridge
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 Unigraft device was evaluated comparatively against a predicate device using a variety of test methods. The results of these tests demonstrate that the Unigraft device is substantially equivalent to a predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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))
1. Submitter
| Name: | Unicare Biomedical, Inc. |
|---|---|
| Address: | 25951 La Cuesta Avenue, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-362-1772 |
| Date: | November 5, 1999 |
2. Device Name
| Trade Name: | Unigraft |
|---|---|
| Common Name: | Synthetic bone graft material |
| Classification Name: | Endosseous implant for bone filling and augmentation |
| Device Classification: | Class III |
3. Predicate Devices
PerioGlas®, BioGran® and others
4. Device Description
Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.
The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.
5. Comparison with Predicate Devices
The Unigraft 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 PerioGlas®. BioGran® and OsteoGraf. These products are made of bioactive ceramic materials with similar performance.
6. Device Testing
The Unigraft device was evaluated comparatively against a predicate device using a variety of test methods. The results of these tests demonstrate that the Unigraft device is substantially equivalent to a predicate device.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2000
Stan Yang, Ph.D. Unicare Biomedical, Incorporated 25951 La Cuesta Avenue Laquna Hills, CA 92653
Re : K993784 Trade Name: Unigraft Requlatory Class: Unclassified Product Code: LYC Dated: November 5, 1999 Received: November 8, 1999
Dear Dr. Yang:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Paqe 2 - Dr. Yang
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda,gov/cdrh/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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510(K) NUMBER: K99-3784 DEVICE NAME: UNIGRAFT INDICATIONS FOR USE:
For the repair of periodontal infrabony defects, extraction site 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 Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
610(k) Number 2993784