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K Number
K014059
Device Name
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
Manufacturer
PULPDENT CORP.
Date Cleared
2002-02-27

(79 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel to adhere orthodontic brackets to tooth surfaces.

Device Description

PULPDENT TRANS OBA Orthodontic Bracket Adhesive is a light-cure, single component dental adhesive in paste form used with a liquid primer and an enamel etching gel.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental adhesive. It does not contain any information about acceptance criteria or a study proving device performance.

Therefore, I cannot fulfill your request for the specific details you've asked for. The document is strictly a regulatory clearance and does not include scientific study results or performance metrics.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.