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K Number
K030318
Device Name
P2 POLYETHER
Manufacturer
HERAEUS KULZER, INC.
Date Cleared
2003-04-03

(63 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding their P2 Polyether Impression Material. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, or MRMC studies. Therefore, I cannot fulfill your request for that specific information based on the provided text.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).