LogoFDA 510(k) Search
K Number
K140602
Device Name
FLASH PENTA MB QUICK, FLASH MB QUICK
Manufacturer
3M ESPE AG
Date Cleared
2014-06-05

(87 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K120438
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

All types of impressions, e.g .:
· Crown, bridge, inlay, and onlay preparations
· Implants
· Orthodontic impressions

Device Description

Flash Penta™ MB Quick and Flash MB Quick are addition type silicone impression materials of medium consistency. Flash Penta MB Quick is mixed in the Pentamix mixing device, while Flash MB Quick can be applied directly using the Garant™ dispenser. Both products are used in mono-phase technique and in one-step technique.

AI/ML Overview

The provided text describes a 510(k) submission for dental impression materials (Flash Penta™ MB Quick and Flash MB Quick). It primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical properties. However, it does not contain the detailed information requested regarding acceptance criteria, study design for proving device acceptance, or any elements related to AI/algorithm performance.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about sample sizes, ground truth, experts, or MRMC studies as these are not mentioned in the provided document.

To be specific about what is mentioned:

  • Device: Flash Penta™ MB Quick and Flash MB Quick (VPS impression material).
  • Study Type: Bench testing.
  • Properties Evaluated: Consistency, total working time, detail reproduction, linear dimensional change, compatibility with gypsum type 3 / type 4, recovery from deformation and strain in compression.
  • Purpose: To demonstrate substantial equivalence to predicate devices (Flash Penta™ HB Q, Flash Heavy Body Q, Flash Regular Body Q, Flash Light Body) in terms of intended use, indications for use, composition, and physical properties.

The document states that a "biocompatibility assessment was developed... using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines" and concluded that the products are safe for their intended use. However, no specific details of this assessment's methods or results are provided.

In summary, the provided document does not contain the information necessary to fulfill your request for details on acceptance criteria, a study proving device acceptance, or any AI/algorithm-related performance metrics.

§ 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).