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K Number
K012438
Device Name
MODIFICATION TO PANAVIA 21
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-05

(36 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K933030
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PANAVIA 21 is indicated for the following applications:

  1. Cementation of adhesion bridges or splints
  2. Cementation of metal crowns, bridges and inlays/onlays
  3. Cementation of silanated porcelain and cured composite crowns or inlays/onlays
  4. Cementation of preformed posts or cast post and cores
  5. Bonded amalgam restoratios
Device Description

This product is a device composed of materials such as dimethaclylate monomers intended to affix dental devices such as crowns or bridges. It is classified into Dental cement other than zinc oxide-eugenol, CFR 29 Section 872.3275.

AI/ML Overview

This submission describes a 510(k) premarket notification for a change in manufacturer name and address for an existing device, PANAVIA 21. As such, the submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The manufacturer explicitly states, "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes," and "This device is essentially the same as PANAVIA 21 manufactured by Kuraray Co., Ltd. (K933030). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as PANAVIA 21."

Therefore, the requested details regarding acceptance criteria and studies are not available in the provided document.

§ 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.