LogoFDA 510(k) Search
K Number
K102753
Device Name
TURBO TEMP 3
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2011-02-04

(134 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

Device Description

Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

AI/ML Overview

I am sorry, but the provided text from the FDA letter regarding K102753 does not contain information about acceptance criteria, device performance results, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any information about AI or MRMC studies.

The document is a 510(k) clearance letter for a temporary crown and bridge material called "Turbo Temp 3," indicating it has been found substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulation name, regulatory class, and product code, along with general regulatory information and contact details.

Therefore, I cannot provide the requested table and study details based on the given input.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.