ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT

• K Number: K994261
• Device Name: ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
• Manufacturer: ULTRADENT PRODUCTS, INC.
• Date Cleared: 2000-02-02 ( 47 days)
• Product Code: EMA
• Regulation Number: 872.3275
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, orowns and bridges. It is polycarboxylate based and does not negatively affect resin bonding. Being water soluhle until set, it cleans up easily.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding a dental cement called UltraTemp Temporary Polycarboxylate Cement. It is not an AI/ML device, therefore, the requested information about acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable.

The document indicates that the device has been found substantially equivalent to predicate devices marketed before May 28, 1976, and can therefore be marketed subject to general controls provisions of the Act.

The "Indications For Use" section on page 2 defines the purpose of the device:

• Device Name: UltraTemp Temporary Polycarboxylate Cement
• Indications For Use: UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, crowns, and bridges. It is polycarboxylate-based and does not negatively affect resin bonding. Being water-soluble until set, it cleans up easily.

Regulation Number and Section

§ 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.