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K Number
K142881
Device Name
DMRC Dual Cure Orthodontic Band Cement
Manufacturer
DANVILLE MATERIALS, LLC.
Date Cleared
2015-02-13

(134 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
K073697
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DMRC Dual Cure Orthodontic Band Cement is a dual-cure adhesive intended for use as an orthodontic band cement for bonding of orthodontic bands to enamel

Device Description

DMRC Dual Cure Orthodontic Band Cement is a resin based material containing a dual-cure adhesive for cementation of orthodontic bands. The DMRC Dual Cure Orthodontic Band Cement is a polymer based filling and restorative material; it contains a base and catalyst for dual curing process as orthodontic band cement.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a dental adhesive device, DMRC Dual Cure Orthodontic Band Cement. This type of document is for regulatory clearance of a medical device and thus does not include information on acceptance criteria for software, detailed clinical study designs, or AI performance metrics.

Therefore, I cannot provide the requested information for the following reasons:

  1. The document is not about AI software or a device that uses AI. It concerns a dental adhesive for orthodontic bands, which is a physical material, not a digital diagnostic or treatment support tool.
  2. The document does not detail acceptance criteria for software performance. The "acceptance criteria" mentioned in the context of the device are for its physical properties and biocompatibility, not for accuracy, sensitivity, or specificity of an algorithm.
  3. No study is mentioned that proves the device meets AI-specific acceptance criteria. The "studies" mentioned are non-clinical bench tests (Vickers Hardness, Ultradent Bracket Shear Bond Strength, Work and Set times, ISO 10993 cytotoxicity) to demonstrate performance comparable to a predicate device. These are standard for material-based medical devices.
  4. There is no mention of sample sizes for test sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, as these are all relevant to AI/software performance evaluation, which is not applicable to this device submission.

In summary, the provided text does not contain any information relevant to the acceptance criteria or study design for an AI-powered medical device.

§ 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.