(88 days)
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No
The summary describes a bone graft material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is described as a material for filling bone defects, not as a device that delivers therapy or treatment. Its function is to fill empty spaces in the bone.
No
Explanation: The device description and intended use indicate that OsteoGraf/N-300 is a filling material for periodontal and bony defects. It is a hydroxylapatite substance used for augmentation, not for diagnosing medical conditions.
No
The device description clearly states that OsteoGraf/N-300 is a physical material (hydroxylapatite particles) intended for filling bony defects, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for filling and augmenting bony defects. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the physical composition and form of the material, which is implanted into the body. This is consistent with a medical device used for surgical procedures, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD tests.
Therefore, OsteoGraf/N-300 is a medical device used for surgical implantation, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
periodontal defects, bony defects of the alveolar ridge, tooth extraction sites
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
OsteoGraf/D-700
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.
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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)
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§ 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
K960348
X960348
510(k) SUMMARY
January 22, 1996
APR 22 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
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- Submitter: CeraMed Corporation 12860 West Cedar Drive Lakewood, CO 80228 (303) 985-0800
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- Device Name: OsteoGraf/N-300 Hydroxylapatite Classification Name: Endosseous implant for bone filling and/or augmentation
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- Predicate Device: OsteoGraf/D-700 (previously OsteoGraf/AR) and others
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- Device Description:
OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.
- న్. Intended Use: The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.
- ર્ભ. Comparison of Product Characteristics: OsteoGraf/N-300 consists of 100% anorganic hydroxylapatite, Ca10(PO4),OHz,
X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/N-300 to be 100% hydroxylapatite. OsteoGraf/N-300 conforms to the requirements of ASTM standard #F1581, "Composition of Anorganic Bone for Surgical Implants."