TETRIC FLOW

• K Number: K993783
• Device Name: TETRIC FLOW
• Manufacturer: IVOCLAR NORTH AMERICA, INC.
• Date Cleared: 1999-12-13 ( 35 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

• Class V restorations (cervical caries, root erosion, wedge shaped defects)
• Anterior restorations (Class III and IV)
• Small posterior restorations
• Restorative therapy for mini-cavities, of all types (preparation with Sonic-Sys Micro Instruments from KaVo)
• Adhesive cementation of Sonic-Sys Inlays
• Extended fissures sealings in molars and pre-molars
• Repair of composite/ceramic veneers
• Blocking out of undercuts
• Adhesive cementation of ceramic and composite restorations

Device Description

Light activated hybrid composite

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a clearance letter from the FDA for a dental composite called "Light activated hybrid composite" (Trade Name: Tetric Flow), indicating it is substantially equivalent to existing devices and can be marketed.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the given text.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.