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K Number
K962786
Device Name
OSTEOGRAF STAINLESS STEEL SYRING
Manufacturer
CERAMED CORP.
Date Cleared
1996-08-01

(15 days)

Product Code
LYC
Regulation Number
872.3930
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Delivery of restorative and impression material.

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device: "OsteoGraf stainless steel syringe." This document describes the device, its intended use, and compares it to predicate devices.

However, the text does not contain any information about:

  1. Acceptance criteria or reported device performance for clinical or diagnostic efficacy. This device is a syringe for delivering restorative and impression material, implying its performance would be related to material delivery consistency, sterility, biocompatibility, and mechanical integrity, not diagnostic accuracy.
  2. Study design, sample sizes (test or training sets), data provenance, expert qualifications, adjudication methods, or ground truth establishment. These elements are typically found in clinical studies or performance validation reports for devices that make diagnostic or prognostic claims. A syringe is a delivery tool, not a diagnostic one.
  3. MRMC comparative effectiveness studies or standalone algorithm performance. These are relevant for AI/ML-driven diagnostic devices, which this syringe clearly is not.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The K962786 document is a regulatory submission focused on demonstrating substantial equivalence for a non-diagnostic device, not a performance study as you've outlined.

§ 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.