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Dentsply Sirona Orthodontics Essix Plastic - HSA Registration DE0508948

Access comprehensive regulatory information for Dentsply Sirona Orthodontics Essix Plastic in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508948 and owned by Dentsply Sirona Orthodontics Inc.. The device was registered on February 13, 2024.

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
DE0508948
Dentsply Sirona Orthodontics Essix Plastic
HSA Registration Number: DE0508948
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Product Description

Essix A+® Plastic is thermoformed to fabricate intra-oral appliances such as bite planes, splints, and snoring appliances. Essix ACE® Plastic/Essix® PLUS Plastic is thermoformed to fabricate intra-oral appliances such as retainers, aligners for minor tooth movement, and temporary bridges. Essix Plastic is suitable for use with non- bruxers/grinders.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0508948
Registration Date
February 13, 2024
Retention Due Date
February 12, 2026
Product Owner
Short Name
Dentsply Sirona Orthodontics Inc.
Address
7290 26th Court East, Sarasota FL 34243, UNITED STATES
Registrant
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model Information
Model Name(s)
Essix A+® Plastic .020 x 4.92"' Square 100PK Essix A+® .020 x 5" square 100PK Essix A+® Plastic .030 x 4.92" Square 100/PK Essix A+ ® Plastic .030  x 5" Vacuum Square 100PK Essix A+® Plastic .030  x 5" Vacuum Square 50PK Essix A+® plastic .040 x 4.92" square 100PK Essix A+ ® Plastic .040 x 5" PETG Vacuum   Square 100PK Essix A+® Plastic .040 x 5" PETG Vacuum Square 50Pk Essix A+® Plastic .060 x 4.92" Square 50 PK Essix A+® Plastic .060 x 5" Square 50PK Essix A+® Plastic .080 x 125 50Pk Essix A+® Plastic .080 x 5" Square 50PK Essix A+® Plastic .020 x 125mm circle 100PK Essix A+® plastic .020 x 120mm circle 100PK Essix A+® Plastic .030 x 125mm Circle 100PK Essix A+® Plastic .030  x 120mm Vacuum Circles 100PK Essix A+® .040 x 125mm Circle (100PK) Essix A+® Plastic .040 x 120mm Circle 100PK Essix A+® Plastic .060  x 125mm  Vacuum Circles 50PK Essix A+® Plastic .060  x 120mm  Circles 50PK Essix A+® Plastic .080  x 125mm Vacuum Circles 50PK Essix A+® .080 x 120mm Circle 50/PK Essix A+ Plastic .120 x 120mm Circle 25PK Essix A+® Plastic .120 x 125mm Circle 25PK Essix A+® plastic .120mm x 5" Square 25/PK Essix ACE® 030 x 120mm Vacuum Circle 100pk Essix ACE® .030  x 120mm Circle 50pk Essix ACE®  030 x 125mm Vacuum Circle 100pk Essix ACE® .030 x 125mm Circle 50pk Essix ACE® 030 x 125mm Square 100/PK Essix ACE® 030 x 5" PCTG Vacuum Square 100pk Essix ACE .030  x 5" PCTG Square 50pk Essix ACE® 040 x 120mm Vacuum Circle 100pk Essix ACE® .040  x 120mm Circle 50pk Essix ACE® 040 x 125mm Vacuum Circle 100pk Essix ACE® .040  x 125mm Circle 50pk Essix ACE® 040 x 5" x 5"  PCTG Vacuum Square 100pk Essix ACE® .040  x 5" PCTG Square 50pk Essix ACE® 040 x 4.875" PCTG Vacuum Square 100pk Essix ACE® .035"  120mm Circle 100/PK Essix ACE® Plastic 035 x 125mm Circle 100pk Essix ACE® Plastic - .035in  125mm Square 100pk Essix ACE® Plastic .035 x Vacuum Square 100pk Essix® PLUS (TM) Plastic 80 ct .035 (7/8mm) -120mm circle Essix® PLUS (TM) Plastic 80 ct .035 (7/8mm) -125mm circle Essix® PLUS (TM) Plastic 80 ct .035 (7/8mm) -125mm square Essix® PLUS (TM) Plastic 80 ct .035 (7/8mm) -5" square Essix® PLUS (TM) Plastic 80 ct .040 (1 mm) -120mm circle Essix® PLUS (TM) Plastic 80 ct .040 (1 mm) -125mm circle Essix® PLUS (TM) Plastic 80 ct .040 (1mm) -125mm Square Essix® PLUS (TM) Plastic 80 ct .040 (1mm) -5" Square
Model Identifier(s)
10020 10025 10030 10035 10035-50 10040 10045 10045-50 10060 10065 10080 10085 11020 11021 11030 11031 11040 11041 11060 11061 11080 11081 13120 13125 13500 1A320 1A320-50 1A325 1A325-50 1A347 1A350 1A350-50 1A420 1A420-50 1A425 1A425-50 1A450 1A450-50 1A478 1AH20 1AH25 1AH347 1AH50 1APL35C120 1APL35C125 1APL35S125 1APL35S5 1APL40C120 1APL40C125 1APL40S125 1APL40S5