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K Number
K101044
Device Name
RETRIEVE IMPLANT CEMENT
Manufacturer
PARKELL, INC.
Date Cleared
2010-06-10

(57 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K033309,K982400,K031212
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

RETRIEVE Implant Cement is a resin-based, self-curing, dual-component dental cement. It is intended for mid- to long-term (semi-permanent) cementation of porcelain, ceramic, resin, and metal-based dental prostheses to dental implants, while allowing retrieval of the prostheses, if necessary. Retrieve can also be used as a temporary filling material.

Device Description

RETRIEVE is an acrylate- and methacrylate-based resin cement for semi-permanent cementation of porcelain, ceramic, resin and metalbased dental prostheses to dental implants. The cement is not considered fully "permanent," and is therefore substantially equivalent to temporary cements, because its bond strength is high enough to maintain the prosthesis in place during normal wear, but low enough to allow for removal by a dental professional for maintenance, replacement, and/or hygienic cleaning. RETRIEVE Implant Cement is a resin-based, self-curing, dual-component dental cement. RETRIEVE dental implant cement is a two-part cement and is typically supplied in a double-barrel, auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and self-cures.

AI/ML Overview

§ 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.