(15 days)
OsteoGraf glass syringe, Bio-Interfaces syringe
Not Found
No
The device description is purely mechanical and there is no mention of AI, ML, or any related concepts like image processing or performance metrics associated with algorithmic analysis.
No
The device is used for the delivery of restorative and impression material, which is a supportive function rather than a direct therapeutic intervention.
No
Explanation: The device is described as a syringe used for the "delivery of restorative and impression material," which indicates a functional or procedural use rather than a diagnostic one.
No
The device description explicitly states it is composed of physical components (stainless steel barrel, polypropylene plunger, rubber plunger tip), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Delivery of restorative and impression material." This describes a device used for a procedure performed on a patient, not for testing samples from a patient to diagnose or monitor a condition.
- Device Description: The description of the syringe components (stainless steel barrel, polypropylene plunger, rubber plunger tip) aligns with a device used for delivering substances, not for performing in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
Delivery of restorative and impression material.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The OsteoGraf stainless steel syringe is a device used for the delivery of restorative and impression material. It is composed of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 glass syringe, Bio-Interfaces syringe
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.
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
July 15, 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
-
- Submitter: CeraMed Corporation 12860 West Cedar Drive Lakewood, CO 80228 (303) 985-0800
-
- Device Name: OsteoGraf stainless steel syringe Classification Name: Syringe for Restorative and Impression Material
-
- Predicate Device: OsteoGraf glass syringe Bio-Interfaces syringe
-
- Device Description: The OsteoGraf stainless steel syringe is a device used for the delivery of restorative and impression material. It is composed of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.
- ર . Intended Use: Delivery of restorative and impression material.
-
- Comparison of Product Characteristics: The OsteoGraf stainless steel syringe consists of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.