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K Number
K972553
Device Name
LANG DENTAL RESIN A97 FIBRED PINK
Manufacturer
LANG DENTAL MFG. CO., INC.
Date Cleared
1997-11-13

(128 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

Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin developed for the fabrication of removable partial dentures and for reconditioning dentures for processes such as repairs, relines and modulation of margins and extension.

Device Description

Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental resin. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily focused on the substantial equivalence determination for the Lang Dental Resin A97 Fibred Pink.

Therefore, I cannot extract the requested information as it is not present in the given text.

§ 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.