IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR

• K Number: K991996
• Device Name: IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
• Manufacturer: DENPLUS, INC.
• Date Cleared: 1999-09-08 ( 86 days)
• Product Code: EBI
• Regulation Number: 872.3760
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

IMPACT-PLUS, IMPACT-20, DP97, DP97-20 are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA, along with an "Indications for Use" statement, for dental acrylics. It does not contain any information regarding acceptance criteria, study details, device performance metrics, or ground truth establishment for an AI-powered medical device.

Therefore, I cannot answer your request based on the provided input. The document is a regulatory approval for a physical product (dental acrylics) and not a study report or technical specification for an AI device.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.