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K Number
K012882
Device Name
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
Manufacturer
THERMOELASTIC TECHNOLOGIES, INC.
Date Cleared
2001-11-14

(78 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

Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a dental device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the given input. The document is essentially a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a detailed study report.

§ 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.