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Bisco Adhesive kit for dental composite - HSA Registration DE0013500

Access comprehensive regulatory information for Bisco 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 DE0013500 and owned by Bisco Inc. The device was registered on July 29, 2013.

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
DE0013500
Bisco Adhesive kit for dental composite
HSA Registration Number: DE0013500
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Product Description

A collection of devices intended to be used to bond attachments such as composites, hooks or buttons to the teeth and/or to an orthodontic aligner during dental or orthodontic teeth adjustment. The contents of this kit may include etchant, bonding resin, bonding paste, spatula, brushes, and a paper pad. This is a reusable device.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
HSAMDB00103
HS Code
30064010
Registration Information
Registration Number
DE0013500
Registration Date
July 29, 2013
Change Notification Approval Date
June 07, 2023
Retention Due Date
July 28, 2025
Product Owner
Short Name
Bisco
Address
1100 W, Irving Park Road, Schaumburg, IL 60193, UNITED STATES
Registrant
Address
6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Importer
Address
6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Model Information
Model Name(s)
1 BOTTLE D/E RESIN (6 ML) 1 BOTTLE PRE-BOND RESIN (6 ML) 1 BOTTLE EACH PRIMER A & B SET (6ML EA) 1 BOTTLE PRIMER A (6 ML EA) 1 BOTTLE PRIMER B (6 ML EA) BIS-SILANE PART A&B 6ML BOTTLE EACH ALL-BOND 3 PART A & B SET (6 ML EACH) ALL-BOND 3 RESIN BOTTLE (4ML) ALL-BOND 3 BOTTLE KIT ALL-BOND 3 Bottle Kit Universal Primer Part A&B (6ml) ALL-BOND 2 REFILL KIT 32% Semi-Gel UNI-ETCH w/BAC ALL-BOND 2 Kit with UNI-ETCH 32% w/out BAC Z-PRIME PLUS 4ML BOTTLE PACKAGE Z-PRIME PLUS 2 ML BOTTLE PACKAGE Z-PRIME PLUS 0.5ML BOTTLE PACKAGE ALL-BOND UNIVERSAL STD KIT ALL-BOND UNIVERSAL STD KIT ALL-BOND UNIVERSAL (6ML) BOTTLE PACKAGE ALL-BOND UNIVERSAL BOTTLE PACKAGE ALL-BOND Universal Refill (4ml) ALL-BOND Universal Sample (0.5g) ALL-BOND Universal Refill (50x0.20ml) Unit Dose All-Bond Universal 5 Unit Sample ALL-BOND Universal Refill (100x0.20ml) Unit Dose UNI-ETCH W/BAC 32% 4SYR UNI-ETCH 32% 4 SYR ETCH-37 W/BAC 4 SYR ETCH-37 4 SYR UNI-ETCH W/BAC 32% 5G UNI-ETCH 32% 5G UNI-ETCH 32% 30G UNI-ETCH W/BAC 32% 30G ETCH-37 W/BAC 30G UNI-ETCH 32% Phosphoric Acid (30ml) ETCH-37 Phosphoric Acid w/BAC (30ml) Syringe 4% PORCELAIN ETCHANT GEL BOTTLE (7G) 4% PORCELAIN ETCHANT SYRINGE (5G) 9.5% PORCELAIN ETCHANT REFILL 4% PORCELAIN ETCHANT / BARRIER GEL KIT SELECT HV ETCH 4 SYR PKG SELECT HV ETCH 5G SYRINGE SAMPLE PKG SELECT HV ETCH REFILL PKG SELECT HV ETCH KIT SELECT HV ETCH W/BAC 4 SYR PKG SELECT HV ETCH W/BAC 5G SYRINGE SAMPLE SELECT HV ETCH W/BAC REFILL 30ML PKG SELECT HV ETCH W/BAC KIT ONE-STEP REFILL BTL (4 ML) ONE-STEP REFILL BTL (6 ML) ONE-STEP PLUS 6ML REFILL BTL
Model Identifier(s)
B-2502A B-2506A B-2510A B-2511A B-2512A B-3210P B-36010P B-3608P B-36200K B-36200K-EU B-4110P B-42500A B-42500K-EU B-6001P B-6002P B-6003PS B-72020K B-7202BOK-EU B-7202P B-7202P-AS B-7204P B-72060PS B-73050K B-7305PS B-73100K E-5502EBM E-5502EM E-5503EBM E-5503EM E-5632EBM E-5632EM E-5637E E-5637EB E-5638EB E-56621P E-56741P E-5701E E-5702EP E-5707P E-5720E E-59010P E-59011P E-59060P E-59100K E-59110P E-59111P E-59160P E-59200K U-1101P U-1102P U-2001P