LogoFDA 510(k) Search
K Number
K091613
Device Name
TAKE 1
Manufacturer
KERR CORP.
Date Cleared
2009-10-07

(126 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

Take I is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Device Description

The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and implant impression techniques. Take 1 is a two-part, base/catalyst - paste/paste system. The product is available in three viscosities, Wash, Tray, and Medium.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a dental impression material named "Take 1," confirming its substantial equivalence to a legally marketed predicate device.

The document includes:

  • Contact information for the submitter.
  • Device name, common name, and classification name.
  • Identification of the predicate device (Kerr Corporation, Kerr VPS Impression Material).
  • Device description and intended use.
  • A statement of substantial equivalence to other legally marketed devices.
  • FDA's letter acknowledging the 510(k) premarket notification and confirming substantial equivalence.
  • Information regarding regulatory compliance and contact details for further inquiries.
  • An "Indications for Use" statement for the device.

There is no information regarding specific performance metrics, acceptance criteria, study methodologies, sample sizes for testing or training, expert qualifications for ground truth establishment, adjudication methods, or results of MRMC or standalone studies.

§ 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).