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K Number
K032773
Device Name
DIAMOND D HIGH IMPACT DENTURE ACRYLIC
Manufacturer
MYCONE DENTAL SUPPLY CO., INC.
Date Cleared
2003-09-23

(15 days)

Product Code
EBI
Regulation Number
872.3760
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Mycone Dental's denture material, known as Diamond D, is intended to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "Diamond D High Implant Denture Material." It indicates that the device has been found substantially equivalent to a predicate device. However, the letter does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily states:

  • The device name, regulation number, regulation name, and product code.
  • The FDA's determination of substantial equivalence.
  • General controls and additional controls applicable to the device.
  • Contact information for further inquiries.
  • The "Indications For Use" for the device, which states it is "intended to form new dentures or to repair fractured dentures" and "to be used only by professional dental practitioners who make or repair dentures for patients."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This type of detail would typically be found in the 510(k) submission document itself, not in the clearance letter.

§ 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.