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K Number
K971138
Device Name
DINABASE (TM)
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
1997-07-21

(115 days)

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

Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or details of a study that proves a device meets acceptance criteria. The document is a 510(k) premarket notification approval letter for a dental device called "Dinabase™", indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It also includes the intended use of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given information.

§ 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.