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K Number
K190571
Device Name
StoneBite and StoneBite scan
Manufacturer
Dreve Dentamid GmbH
Date Cleared
2019-11-07

(246 days)

Product Code
ELW
Regulation Number
872.3660
Type
Abbreviated
Panel
DE
Reference & Predicate Devices
K171562,K081017,K021410,K053427,K081120
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.

StoneBite® is indicated for:

  • bite registrations
  • I key for intraoral registration

StoneBite® scan is indicated for:

  • i bite registrations
  • key for intraoral registration
  • . optical collection of data in CAD/CAM/CIM systems
Device Description

StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record.

StoneBite and StoneBite scan are vinyl polysiloxane based materials.

StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.

AI/ML Overview

The document describes the non-clinical performance testing for dental impression materials, specifically StoneBite and StoneBite scan. This is not medical AI device and therefore does not contain any of information requested.

§ 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).