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K Number
K213965
Device Name
BeautiBond Xtreme
Manufacturer
Shofu Dental Corporation
Date Cleared
2022-03-18

(88 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Direct restorations with light-cured composite resin
  • Repair of fractured restorations with light-cured composite resin
  • Post cementation and core build-up
  • Cementation of indirect restorations with light-cured/dual-cured resin cement
  • Treatment of hypersensitive teeth or exposed root surface
  • Sealing of tooth preparation (cavity or abutment) for indirect restorations
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving the device meets those criteria.

The document is an FDA 510(k) clearance letter for a dental bonding agent named "BeautiBond Xtreme." It primarily

  • Confirms the FDA's review and determination of substantial equivalence for the device.
  • Outlines the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
  • Lists the indications for use of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.