(29 days)
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No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No
The device is used for the delivery of restorative and impression material, which are typically used in dentistry for procedures like filling cavities or taking impressions for crowns, not for treating a disease or condition itself.
No
The "Intended Use / Indications for Use" states "Delivery of restorative and impression material.", which describes a function of administering substances, not diagnosing conditions.
No
The device description clearly states it is composed of physical components (plastic barrel, polypropylene plunger, and 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 to physically deliver substances into or onto the body, not to perform tests on samples taken from the body.
- Device Description: The description of the syringe components (plastic barrel, plunger, tip) aligns with a device for material delivery, not for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
Delivery of restorative and impression material.
Product codes
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Device Description
The PermaRidge syringe is a device used for the delivery of restorative and impression material. It is composed of a plastic barrel, polypropylene plunger, and rubber plunger tip.
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
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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
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Key Metrics
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Predicate Device(s)
OsteoGraf glass syringe Bio-Interfaces syringe
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
AUG 2 0 1996
510(k) SUMMARY
July 20, 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: PermaRidge syringe Classification Name: Syringe for Restorative and Impression Material
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- Predicate Device: OsteoGraf glass syringe Bio-Interfaces syringe
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- Device Description: The PermaRidge syringe is a device used for the delivery of restorative and impression material. It is composed of a plastic barrel, polypropylene plunger, and rubber plunger tip.
- న్. Intended Use: Delivery of restorative and impression material.
- Comparison of Product Characteristics: 6, The PermaRidge syringe consists of a plastic (cellulose acetate propionate) barrel, polypropylene plunger, and rubber plunger tip.