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K Number
K112307
Device Name
RESIGLASS PASTE
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2012-03-28

(230 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ResiGlass Paste is intended for cementation of permanent restorations including crowns and bridges etc. to natural teeth and other materials.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter for "RESIGLASS PASTE" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory information such as:

  • Trade/Device Name: RESIGLASS PASTE
  • Regulation Number and Name: 21 CFR 872.3275, Dental Cement
  • Regulatory Class: II
  • Product Code: EMA
  • Indications For Use: Cementation of permanent restorations including crowns and bridges etc. to natural teeth and other materials.
  • Approval Date: March 28, 2012

This type of document does not typically include detailed performance study results or acceptance criteria, which would usually be found in the 510(k) submission itself or in a summary of safety and effectiveness.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.