MICROHYBRID 11

• K Number: K022971
• Device Name: MICROHYBRID 11
• Manufacturer: AB ARDENT
• Date Cleared: 2002-11-25 ( 80 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV

Class V restorations, cervical caries, root erosion, wedge shaped defects.

Posterior restorations, Class I, II.

Splinting of mobile teeth.

Preventive restorations in molars and premolars.

Repair of composite and ceramic veneers.

Inlays/onlays with extra-oral post tempering

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) premarket notification letter for a dental device called "Microhybrid 11," primarily focusing on its substantial equivalence determination. It lacks details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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.