ARISTON PHC LINER

• K Number: K981335
• Device Name: ARISTON PHC LINER
• Manufacturer: IVOCLAR NORTH AMERICA, INC.
• Date Cleared: 1998-07-02 ( 80 days)
• Product Code: EMA
• Regulation Number: 872.3275
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Intended Use: Ariston pHc Liner is intended to be used as an adhesive for direct light curing composite and compomer restorations.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for the Ariston pHc Liner and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.

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

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.