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K Number
K080724
Device Name
GC OPB-100
Manufacturer
GC AMERICA, INC.
Date Cleared
2008-06-11

(89 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

GC OPB-100 is intended to be used for cementation of orthodontic bands. It is also used for the cementation of appliances retained with stainless steel crowns (e.g., Herbst or expansion appliances).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from K080724 is a 510(k) clearance letter from the FDA for a dental bonding agent (GC OPB-100). This type of document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the way you've requested.

Specifically, this document is a notification of substantial equivalence to a predicate device, which means the FDA determined it is as safe and effective as a legally marketed device. It does not elaborate on the specific performance studies, acceptance criteria, or statistical details often found in performance reports or clinical trial summaries.

Here's why the requested information cannot be extracted from this document:

  • Acceptance Criteria and Reported Device Performance: This letter focuses on regulatory clearance, not on presenting performance metrics against specific acceptance criteria.
  • Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, and Training Set Ground Truth: These details are part of the underlying technical data and studies submitted by the manufacturer to the FDA, but they are not included in this summary clearance letter.

To answer your questions, one would need access to the full 510(k) submission, which is typically not publicly available in this level of detail. The provided document only serves as confirmation of regulatory clearance based on a determination of substantial equivalence.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.