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K Number
K080517
Device Name
RESICEM
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2008-06-11

(107 days)

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

RESICEM is a dual cured, visible light cured, and self cured dental adhesive resin cement and is intended for adhesion between any two of the following: dental restoration, dental restorative material, dental device, and natural teeth.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for a dental cement called ResiCem. It determines that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

The document does not contain information about:

  • Acceptance criteria and reported device performance: While it states the device is "substantially equivalent," it does not provide specific performance metrics or acceptance criteria used to reach this conclusion.
  • Study details: There is no mention of any specific studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. This type of detailed study information is not typically included in the 510(k) clearance letter itself, but rather in the full 510(k) submission which is not provided here.

Therefore, I cannot provide the requested table or answer the specific questions about the study from the provided text. The document is essentially an approval letter, not a scientific study report.

§ 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.