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K Number
K990448
Device Name
THE.R.MO.FREE
Manufacturer
DENTAMAX, INC.
Date Cleared
1999-03-23

(39 days)

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

Fabrication or repair of bases for partial or full dentures.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device named "THE.R.MO.FREE" used for the "Fabrication or repair of bases for partial or full dentures."

However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance letter based on substantial equivalence to a predicate device, not a performance study report.

Therefore, I cannot provide the requested information from this document. The sections you asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in clinical study reports or comprehensive device testing summaries, which are not part of this 510(k) 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.