K Number
K040951
Device Name
SR ADORO
Date Cleared
2004-05-19

(37 days)

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

For Metal Supported restorations with conventional cementation
For Metal Supported restorations using SR Adoro Thermo Guard

  • Veneering of metal supported restorations using SR Adoro Thermon CRA Adoro
  • Veneering of metal supported restorations using ON Pincho Station Thermo Guard
  • Veneering of combined dentures (e.g. telescope veneers) using SFA Adoro Thermo Guard
  • Veneering of combined dentares (e.g. Ichoope veng SR Adoro Thermo Guardina
    Veneering of partially removable implant superstructures using SPAArco
  • Veneering of partially removable implant superstructures using SF Adoro Themo Guard Guard
  • Fabrication of Iong-term temporaries using SR Adoro Thermo Guard
  • Fabrication of forig-tenn tomporanes with SR Adoro Opaquer Pink.
    For Metal-Free restorations
    With Adhesive Cementation:
  • Inlays/Onlays/Veneers
  • Anterior crowns without Vectris framework
  • Anterior orowns with Vectrist framework
  • Antenor and posterior Crowns was will Wectris framework
  • 3-unit antenor and positis framework
    With Conventional Cementation :
    Conventional Cementation .
  • long-term temporaries with Vectris framework for a maximum duration of wear of 12 months.
  • For removable prosthetics
    For removable prostnetics
  • Surface characterization of Ivoclar Vivadent denture teeth with SR Adoro Stains. Surfaces must subsequently be covered with SR Adolo layering material.
  • Surface characterization with SR Adoro layering material.
  • Shade and shape modifications of Ivociar Vivadent denture teeth with SR Adoro layering material in conjuction with SR Composiv.
Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "SR Adoro®". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses and contraindications.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from the provided text.

§ 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.