(166 days)
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
CharmFlex is impression material. It has 5 types: Putty, Regular, Light, Heavy, Bite.
- CharmFlex®Putty/ CharmFlex®Putty Green/ CharmFlex®Putty Soft CharmFlex®Putty consists of various Putty-bodies type and dental addition silicone impression material made by polymerization as a mixture of Base and Catalyst. In dental treatment, an impression material used to record oral tissue anatomy. CharmFlex®Putty has viscosity of putty consistency classification according to type 0 ISO 4823 classification. Packaging consists of two putty systems which are supplied by in two jars, the one is base and another is catalyst. This product is used for two step impression and the material for the first impression is for recording oral tissue anatomy. Base and catalyst of impression are packed separatelv
- CharmFlex®Heavy cartridge type/ CharmFlex®Heavy tube type CharmFlex® Heavy series are hydrophilic vinyl polysiloxane impression materials type of Heavybodies. It is used for the one-step impressions teeth or individual tooth in the mouth. CharmFlex®Heavy as the additional polymerization silicone type is rubber impression materials that registers oral tissue anatomy. It is used with Light-body for impression taking. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of whole teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials.
- CharmFlex®Regular/ CharmFlex®Denture/ CharmFlex®Light LV/ CharmFlex®Light XLV/ CharmFlex®Light Premium CharmFlex® Light series are hydrophilic vinyl polysiloxane impression material type of LightLV, Regular and LightXLV. It is used for the one-step or two-step impression taking of teeth or individual tooth in the mouth. CharmFlex® Light XLV/Regular series as the additional polymerization silicone type are rubber impression materials that records oral tissue anatomy. Packages are cartridge type which is supplied by from of two syringes. This product is used for the first or second impression taking of teeth or individual tooth in mouth before the final impression taking. It is silicone based dental rubber impression materials.
- CharmFlex®Bite/ CharmFlex®Bite Clear/ CharmFlex®Bite Fast CharmFlex Bite series are bite registration impression material to measure of the occlusal surface. impression of the teeth for a three-dimension position of the mandible in relation to the maxilla. It has a short polymerization time and a high final hardness. Making it suitable for bite registration.
This document is a 510(k) Summary for the medical device "CharmFlex®", a dental impression material. It seeks to prove substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents performance data for three categories of CharmFlex® products against predicate devices. The acceptance criteria aren't explicitly stated as numerical targets in a separate section, but are implicitly defined by performing the tests against established ISO standards (ISO 4823 for Dentistry-Elastomeric impression materials) and comparing the results to those of legally marketed predicate devices. The "reported device performance" are the values listed for the "Subject Device" in the comparison tables.
Here's a consolidated table, noting that specific numerical acceptance criteria (e.g., "must be
§ 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).