(84 days)
OsteoGraf/D-700
Not Found
No
The device description focuses on the material composition and physical properties of a bone graft substitute, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used for "filling of periodontal defects and augmentation of bony defects," which indicates it is used for the treatment or amelioration of a condition, thus classifying it as a therapeutic device.
No
The device is described as a material for filling periodontal and bony defects, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly states it is a "high purity, radiopaque, polycrystalline form of hydroxylapatite," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of OsteoGraf/LD-300 is for filling and augmenting bony defects within the body (periodontal defects and alveolar ridge).
- The device description focuses on the material properties and physical form of the implant. It doesn't mention any components or processes related to analyzing biological samples.
- There is no mention of any laboratory testing or analysis of patient samples.
The device described is a medical device intended for surgical implantation to aid in bone regeneration.
N/A
Intended Use / Indications for Use
The intended use of OsteoGraf/LD-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.
Product codes
Not Found
Device Description
OsteoGraf/LD-300 is a high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as rounded, irregular shaped synthetic 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
periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites
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)
OsteoGraf/D-700
Reference Device(s)
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
January 22, 1996
APR 18 1995
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/LD-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
4. Device Description:
OsteoGraf/LD-300 is a high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as rounded, irregular shaped synthetic hydroxylapatite particles, sized at 250-420 microns.
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- Intended Use: The intended use of OsteoGraf/LD-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.
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- Comparison of Product Characteristics: OsteoGraf/LD-300 consists of 100% anorganic hydroxylapatite, Ca1o(PO4),OH2.
X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/LD-300 to be 100% hydroxylapatite. OsteoGraf/LD-300 conforms to the requirements of ASTM standard #F1185, "Composition of Ceramic Hydroxylapatite for Surgical Implants."