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K Number
K962747
Device Name
PULPDENT ENDODONTIC POST CEMENT KIT
Manufacturer
PULPDENT CORP.
Date Cleared
1996-09-30

(77 days)

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

Pulpdent ENDODONTIC POST CEMENT KIT is a convenience package of dental materials used by the dentist to prepare the root canal and cement an endodontic post into the canal prior to core build up.

Device Description

The kit contains one 4.5 gram syringe each of resin cement base and catalyst, one 10 ml bottle of bonding agent, 34 ml each of 17 % EDTA solution and 5.25 % sodium hypochlorite solution, plastic wells, mixing paper, mixing sticks and applicator tips.

AI/ML Overview

This document, K962747, describes a Pulpdent Endodontic Post Cement Kit, which is a dental material and not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are standard for evaluating AI/ML medical devices, is not applicable in this context.

The document focuses on:

  • Description and Intended Use: Explaining what the kit is and how it's used.
  • Comparison with Predicate Products: Stating its substantial equivalence to previously approved devices.
  • Safety and Effectiveness: Referencing general statements about dental restorative materials and specific components (EDTA and sodium hypochlorite) from established authorities like NIH and ADA. These are general statements about the categories of materials, not specific studies on this particular product demonstrating its performance against predefined acceptance criteria in a clinical setting.

Therefore, I cannot extract the requested information as it pertains to AI/ML powered medical devices.

§ 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.