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K Number
K053427
Device Name
FRESH, DENTAL IMPRESSION MATERIAL
Manufacturer
EXACTA DENTAL PRODUCTS, INC.
Date Cleared
2006-01-13

(36 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

Fresh, Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

Device Description

The Fresh, Dental Impression Material is described as a Class II , impression material that is used to reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant.

AI/ML Overview

The provided document describes the "Fresh, Dental Impression Material" and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.

The document states:

  • The device is a Class II material, regulated under 21 CFR part 872.3660, Product Code: ELW.
  • It's designed to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal, and dental implants.
  • The material is based on the principle of mixing base and catalyst components to produce an accurate reproduction of the patient's dentition.
  • The material is compared to a predicate device, K 052090, Splash Dental Impression Material, for substantial equivalence.
  • It has benefited from design, development, testing, and production procedures certified to ISO 9001 and ISO 14385, and the EU Declaration of Conformity for Medical Products.
  • It states that the material "is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy." However, no specific test results, acceptance criteria, or study details are provided to support this claim.

Therefore, I cannot provide the requested information because it is not present in the given text. The document is primarily a 510(k) summary and the FDA's clearance letter, focusing on substantial equivalence to a predicate device rather than detailed performance study results.

§ 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).