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Ormco Bondable Lingual Retainer - HSA Registration DE0509438

Access comprehensive regulatory information for Ormco Bondable Lingual Retainer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509438 and owned by Ormco Corporation. The device was registered on June 21, 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
DE0509438
Ormco Bondable Lingual Retainer
HSA Registration Number: DE0509438
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Product Description

The intended use of bondable lingual retainers is to stabilize the dental arch following orthodontic treatment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0509438
Registration Date
June 21, 2024
Retention Due Date
June 20, 2025
Product Owner
Short Name
Ormco Corporation
Address
200 S Kraemer Blvd, Brea, California 92821, UNITED STATES
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-308, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model Information
Model Name(s)
BONDABLE LINGUAL RETAINER CUSPID 0 BONDABLE LINGUAL RETAINER CUSPID 1 BONDABLE LINGUAL RETAINER CUSPID 2 BONDABLE LINGUAL RETAINER CUSPID 3 BONDABLE LINGUAL RETAINER CUSPID 4 BONDABLE LINGUAL RETAINER CUSPID 5 BONDABLE LINGUAL RETAINER CUSPID 6
Model Identifier(s)
204-0010 204-0011 204-0012 204-0013 204-0014 204-0015 204-0016