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Pentron Dental Adhesive Kit for Dental Composite - HSA Registration DE0500411

Access comprehensive regulatory information for Pentron Dental Adhesive Kit for Dental Composite in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500411 and owned by Pentron Clinical. The device was registered on April 05, 2016.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0500411
Pentron Dental Adhesive Kit for Dental Composite
HSA Registration Number: DE0500411
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Product Description

A kit/pack that contains a collection of devices intended to be used to bond attachments such as hooks or buttons to the teeth and/or to an orthodontic aligner during dental or orthodontic teeth adjustment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HS Code
30064010
Registration Information
Registration Number
DE0500411
Registration Date
April 05, 2016
Retention Due Date
April 04, 2026
Product Owner
Short Name
Pentron Clinical
Address
1717 West Collins Avenue, Orange, California 92867, UNITED STATES
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-303, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
Bond-It Enamel/Dentin Bonding System Bond-It Enamel/Dentin Bonding System 1 - 6ml/4.5 gm Bottle Primer A Bond-It Enamel/Dentin Bonding System 1 - 6ml/5.3 gm Bottle Primer B Bond-It Enamel/Dentin Bonding System 1 - 6ml/4.5 gm Primer A 1 - 6ml/5.3 gm Primer B ( Primers A & B ) Bond-It Enamel/Dentin Bonding System 1 - 6ml/7.2 gm Bottle Resin Light Cure Bond-It Enamel/Dentin Bonding System 1 - 3ml Bottle Dual Cure Activator Bond-It Enamel/Dentin Bonding System 1 - 6ml Bottle Resing Light Cure 1 - 3ml Bottle Dual Cure Activator Resin Light Cure & Dual Cure Activator 37% Etching Gel Phosphoric Acid Etching Gel Bond-1 Primer / Adhesive Bond-1 Primer / Adhesive 1 - 4ml / 3.6gm Bond-1 Primer / Adhesive 1 - 6ml / 5.3gm Bond-1 Dual Cure Activator 1 - 3ml / 2.1gm 37% Etching Gel Phosphoric Acid Etching Gel Bond-1 SF Solvent-Free SE Adhesive Bond-1 SF Solvent-Free SE Adhesive Silane 3ml/2.5gm Disposable Applicators 37% Etching Gel Phosphoric Acid Etching Gel 22 G Bent Needle Tips
Model Identifier(s)
N01 N01A N01B N01C N01D N01E N01F N01H N01I N01IAA N01IAB N01IAC N01IB N03N N03T N04EA N10B T06 T26B