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K Number
K051535
Device Name
MODIFICATION TO:REGISTRADO X-TRA
Manufacturer
VOCO GMBH
Date Cleared
2005-06-28

(18 days)

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

Registrado X-tra is suitable for bite registration. fixing of face bow registration and is a location material for intra-oral pin tracing template

Device Description

Not Found

AI/ML Overview

This document is a marketing clearance letter from the FDA for a dental impression material called "Registrado X-tra". It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically be found in the 510(k) premarket notification summary, which this document references but is not.

Therefore, I cannot provide the requested 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).