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K Number
K040375
Device Name
IDEAL 1 ORTHODONTIC BAND CEMENT
Manufacturer
DENTSPLY INTL.
Date Cleared
2004-04-02

(45 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K033703
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IDEAL® 1 ORTHODONTIC BAND CEMENT is indicated for bonding of orthodontic bands to natural and artificial tooth surfaces.

Device Description

The IDEAL® 1 ORTHODONTIC BAND CEMENT is a light-cure two-part system: an orthodontic cement and a primer. A tooth conditioner is available if desired for the highest stress bonding cases. The cement is packaged in syringes. No mixing is necessary. The primer is packaged in unit dose, self-dispensing capsules.

AI/ML Overview

The provided text is a 510(k) summary for the IDEAL® 1 ORTHODONTIC BAND CEMENT. It focuses on device description, intended use, and technological characteristics, asserting substantial equivalence to predicate devices based on component use and performance data. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria. The document states: "We believe that the prior use of the components of the IDEAL® 1 ORTHODONTIC BAND CEMENT in legally marketed devices, the performance data provided, and the similarity of the prodicate to the new device support the safety and effectiveness of the IDEAL® 1 OILTHODONTIC BAND CEMENT for the intended uses." This implies that the 'performance data' was likely general characterization or referencing of the predicate device's performance, rather than a specific clinical study for this device detailed in the provided text.

Therefore, I cannot extract the requested information in the format provided because the document does not contain:

  1. A table of specific acceptance criteria and reported device performance against them.
  2. Details on sample sizes for test sets, data provenance, or the nature of any "performance data provided."
  3. Information on experts, adjudication methods, or MRMC studies.
  4. Details of a standalone algorithm performance study.
  5. Clarification on the type of ground truth used.
  6. Sample size or ground truth establishment for a training set.

The 510(k) summary primarily addresses the regulatory aspect of demonstrating substantial equivalence to a predicate device (Ideal® 1 Orthodontic Bracket Adhesive K033703) rather than presenting a detailed clinical or performance study for the IDEAL® 1 ORTHODONTIC BAND CEMENT.

§ 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.