PREMIER TEMPORARY CEMENT

• K Number: K051866
• Device Name: PREMIER TEMPORARY CEMENT
• Manufacturer: PREMIER DENTAL PRODUCTS CO.
• Date Cleared: 2005-09-06 ( 57 days)
• Product Code: EMA
• Regulation Number: 872.3275
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Premier Temporary Cement is recommended for the cementation of temporary crowns, bridges, inlays and onlays.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for a dental cement, not an AI/ML device. Therefore, the requested information about acceptance criteria, clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable.

The document discusses substantial equivalence to a predicate device based on regulatory requirements for dental cements, not performance metrics of an AI algorithm.

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.