(29 days)
Delivery of restorative and impression material.
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.
This 510(k) summary for K962838 concerns a medical device (syringe) and not an AI/ML-driven diagnostic or assistive technology. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, ground truth, and AI performance metrics is not applicable to this submission.
The 510(k) summary provided describes a simple physical device called the "PermaRidge syringe" intending to deliver restorative and impression material. The evaluation for such a device typically focuses on:
- Material biocompatibility: Ensuring the materials used are safe for patient contact.
- Sterilization efficacy: Verifying the device can be effectively sterilized without compromising its integrity.
- Functional performance: Confirming the syringe can reliably deliver the intended materials without leakage, premature discharge, or other mechanical failures.
- Comparability to predicate devices: Demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.
The document states, "Comparison of Product Characteristics: 6, The PermaRidge syringe consists of a plastic (cellulose acetate propionate) barrel, polypropylene plunger, and rubber plunger tip." This suggests the primary mechanism for demonstrating safety and effectiveness was likely a comparison of materials and design to existing, approved syringes (predicate devices).
Therefore, it is impossible to provide the requested information in the format of an AI/ML study because this document describes a conventional medical device, not an AI/ML system.
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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.
§ 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.