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K Number
K122974
Device Name
TRYOUT-VPS HOLDING PASTE
Manufacturer
CROWN DELTA CORP.
Date Cleared
2013-05-17

(233 days)

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

Crown Delta's TRYOUT – Translucent Shade VPS Holding Paste is to be used for the temporary stabilization of ceramic crowns and veneers on prepared teeth while the dentist evaluates fit, re-contours and/or trims, and performs an esthetic assessment prior to permanent fixation with cement.

Device Description

TRYOUT - Translucent Shade VPS Holding Paste

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K122974 letter for "TRYOUT - Translucent Shade VPS Holding Paste" does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you have requested.

This document is a letter from the FDA to Crown Delta Corporation stating that their device, TRYOUT - Translucent Shade VPS Holding Paste, is substantially equivalent to a legally marketed predicate device. It confirms the regulatory classification and general controls applicable to the device.

The "Indications for Use" section (page 3) describes the intended use of the product, but it does not include any performance metrics or study results.

Therefore, I cannot provide the requested information based on the text provided.

§ 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.