RTR SYRINGE

• K Number: K063634
• Device Name: RTR SYRINGE
• Manufacturer: SEPTODONT
• Date Cleared: 2007-05-11 ( 156 days)
• Product Code: LYC
• Regulation Number: 872.3930
• Type: Abbreviated
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

RTR® SYRINGE is designed for the replacement of bone losses, after being impregnated with the patient's blood or with a physiological solution for craniofacial indications in the dental practice such as filling tooth sockets.

Device Description

Not Found

AI/ML Overview

The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "RTR® Syringe." It does not contain information about acceptance criteria, device performance studies, or clinical trial data. The document primarily focuses on regulatory approval and the device's indications for use.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
3. Information on MRMC comparative effectiveness studies or standalone performance.
4. Type of ground truth, training set sample size, or how ground truth was established for a training set.

This document is a regulatory approval, not a scientific study report.

Regulation Number and Section

§ 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.