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K Number
K972485
Device Name
CIMPAT N
Manufacturer
ARENT, FOX, KINTNER, PLOTKIN & KAHN
Date Cleared
1997-09-08

(68 days)

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

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text content does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device. The documents are formal letters from the FDA to companies regarding 510(k) premarket notifications, confirming substantial equivalence for two different devices (Cimpat N and Auradapt Abutment System).

These letters discuss:

  • The FDA's review of the premarket notification.
  • The determination of substantial equivalence to predicate devices.
  • Regulatory class and applicable controls (general controls, special controls, or premarket approval).
  • Compliance with Good Manufacturing Practice (GMP) and Quality System Regulation (QS).
  • Information regarding labeling regulations and other responsibilities under the Act.

They do not include details about:

  • Specific performance acceptance criteria for the devices.
  • Any studies, their methodology, sample size, data provenance, ground truth establishment, or expert involvement used to demonstrate device performance against such criteria.
  • Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot extract the requested information from the given 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.