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K Number
K992854
Device Name
ARTIFICIAL TEETH (ACRYLIC TEETH)
Manufacturer
MASTERDENT LTDA.
Date Cleared
2000-02-07

(167 days)

Product Code
ELM
Regulation Number
872.3590
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ACRYLIC TEEHT ARE USE FOR MAKING, FULL AND PARTIAL DENTURES. THE ACRYLIC TEEHT ARE MOUNTED ON A APPLIANCE,MADE OF DENTAL ACRYLIC. ONCE THAT APPLIANCE IS MADE IS FITTED IN TO PATIENT MOUTH THIS APPLIANCE IS REMOVABLE ,IS NOT IMPLANTED.

Device Description

Artificial Teeth (Acrylic Teeth)

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for artificial teeth (acrylic teeth). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The document is regulatory approval, not a scientific study report.

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.