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Straumann BLC Implant System - HSA Registration DE0509595

Access comprehensive regulatory information for Straumann BLC Implant System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509595 and owned by Institut Straumann AG. The device was registered on July 29, 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 C
DE0509595
Straumann BLC Implant System
HSA Registration Number: DE0509595
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Product Description

Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices. Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0509595
Registration Date
July 29, 2024
Change Notification Approval Date
April 16, 2025
Retention Due Date
July 28, 2025
Product Owner
Short Name
Institut Straumann AG
Address
Peter Merian-Weg 12, CH-4002, Basel, SWITZERLAND
Registrant
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #19-05, SINGAPORE 179101
Importer
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #19-05, SINGAPORE 179101
Model Information
Model Name(s)
RB/WB Variobase® for Bridge/Bar Cylindrical Ø 4.5mm, AH 3.5mm, incl. screw & CA3, TAN/POM Plastic Coping for Immediate Temporary Abutment, PMMA CARES® Mono Scanbody for screw-retained abutment abutment level, Ø 4.6mm, PEEK/TAN RB/WB Plan Abutment for Screw-retained Abutments 0°, GH 1.5/2.5/3.5/4.5mm, POM RB/WB Plan Abutment for Screw-retained Abutments 17°, GH 3.5/4.5/5.5mm, POM RB/WB Plan Abutment for Screw-retained Abutments 30°, GH 3.5/4.5/5.5mm, POM Drill handle self-locking, Ø 2.2mm, 1mm/3mm stop, stainless steel Drill handle self-locking, Ø 2.8mm, 1mm/3mm stop, stainless steel Drill handle self-locking, Ø 3.2mm, 1mm/3mm stop, stainless steel Drill handle self-locking, Ø 3.5mm, 1mm/3mm stop, stainless steel Drill handle self-locking, Ø 3.7mm, 1mm/3mm stop, stainless steel Drill handle self-locking, Ø 4.2mm, 1mm/3mm stop, stainless steel T-Sleeve self-locking, guided, Ø 5mm, H 5mm, PEEK BLC/TLC Profile Drill, short, FIBA compatible Ø 3.3mm, L 27mm, stainless steel BLC/TLC Profile Drill, short, FIBA compatible Ø 3.75mm, L 26mm, stainless steel BLC/TLC Profile Drill, short, FIBA compatible Ø 4.5mm, L 26mm, stainless steel BLC/TLC Profile Drill, short Ø 5.5mm, L 26mm, stainless steel BLC/TLC Profile Drill, short Ø 6.5mm, L 26mm, stainless steel BLC/TLC Tap, short, FIBA compatible Ø 3.3mm, L 21mm, stainless steel BLC/TLC Tap, short, FIBA compatible Ø 3.75mm, L 21mm, stainless steel BLC/TLC Tap, short, FIBA compatible Ø 4.5mm, L 21mm, stainless steel BLC/TLC Tap, short Ø 5.5mm, L 21mm, stainless steel BLC/TLC Tap, short Ø 6.5mm, L 21mm, stainless steel BLC Implant Ø 3.3mm RB, SLA® 8mm, Roxolid® BLC Implant Ø 3.3mm RB, SLA® 10mm, Roxolid® BLC Implant Ø 3.3mm RB, SLA® 12mm, Roxolid® BLC Implant Ø 3.3mm RB, SLA® 14mm, Roxolid® BLC Implant Ø 3.3mm RB, SLA® 16mm, Roxolid® BLC Implant Ø 3.3mm RB, SLA® 18mm, Roxolid® BLC Implant Ø 3.75mm RB, SLA® 6mm, Roxolid® BLC Implant Ø 3.75mm RB, SLA® 8mm, Roxolid® BLC Implant Ø 3.75mm RB, SLA® 10mm, Roxolid® BLC Implant Ø 3.75mm RB, SLA® 12mm, Roxolid® BLC Implant Ø 3.75mm RB, SLA® 14mm, Roxolid® BLC Implant Ø 3.75mm RB, SLA® 16mm, Roxolid® BLC Implant Ø 3.75mm RB, SLA® 18mm, Roxolid® BLC Implant Ø 4.5mm WB, SLA® 6mm, Roxolid® BLC Implant Ø 4.5mm WB, SLA® 8mm, Roxolid® BLC Implant Ø 4.5mm WB, SLA® 10mm, Roxolid® BLC Implant Ø 4.5mm WB, SLA® 12mm, Roxolid® BLC Implant Ø 4.5mm WB, SLA® 14mm, Roxolid® BLC Implant Ø 4.5mm WB, SLA® 16mm, Roxolid® BLC Implant Ø 4.5mm WB, SLA® 18mm, Roxolid® BLC Implant Ø 5.5mm WB, SLA® 6mm, Roxolid® BLC Implant Ø 5.5mm WB, SLA® 8mm, Roxolid® BLC Implant Ø 5.5mm WB, SLA® 10mm, Roxolid® BLC Implant Ø 5.5mm WB, SLA® 12mm, Roxolid® BLC Implant Ø 5.5mm WB, SLA® 14mm, Roxolid® BLC Implant Ø 5.5mm WB, SLA® 16mm, Roxolid® BLC Implant Ø 6.5mm WB, SLA® 6mm, Roxolid® BLC Implant Ø 6.5mm WB, SLA® 8mm, Roxolid® BLC Implant Ø 6.5mm WB, SLA® 10mm, Roxolid® BLC Implant Ø 6.5mm WB, SLA® 12mm, Roxolid® BLC Implant Ø 6.5mm WB, SLA® 14mm, Roxolid® BLC Implant Ø 3.3mm RB, SLActive® 8mm, Roxolid® BLC Implant Ø 3.3mm RB, SLActive® 10mm, Roxolid® BLC Implant Ø 3.3mm RB, SLActive® 12mm, Roxolid® BLC Implant Ø 3.3mm RB, SLActive® 14mm, Roxolid® BLC Implant Ø 3.3mm RB, SLActive® 16mm, Roxolid® BLC Implant Ø 3.3mm RB, SLActive® 18mm, Roxolid® BLC Implant Ø 3.75mm RB, SLActive® 6mm, Roxolid® BLC Implant Ø 3.75mm RB, SLActive® 8mm, Roxolid® BLC Implant Ø 3.75mm RB, SLActive® 10mm, Roxolid® BLC Implant Ø 3.75mm RB, SLActive® 12mm, Roxolid® BLC Implant Ø 3.75mm RB, SLActive® 14mm, Roxolid® BLC Implant Ø 3.75mm RB, SLActive® 16mm, Roxolid® BLC Implant Ø 3.75mm RB, SLActive® 18mm, Roxolid® BLC Implant Ø 4.5mm WB, SLActive® 6mm, Roxolid® BLC Implant Ø 4.5mm WB, SLActive® 8mm, Roxolid® BLC Implant Ø 4.5mm WB, SLActive® 10mm, Roxolid® BLC Implant Ø 4.5mm WB, SLActive® 12mm, Roxolid® BLC Implant Ø 4.5mm WB, SLActive® 14mm, Roxolid® BLC Implant Ø 4.5mm WB, SLActive® 16mm, Roxolid® BLC Implant Ø 4.5mm WB, SLActive® 18mm, Roxolid® BLC Implant Ø 5.5mm WB, SLActive® 6mm, Roxolid® BLC Implant Ø 5.5mm WB, SLActive® 8mm, Roxolid® BLC Implant Ø 5.5mm WB, SLActive® 10mm, Roxolid® BLC Implant Ø 5.5mm WB, SLActive® 12mm, Roxolid® BLC Implant Ø 5.5mm WB, SLActive® 14mm, Roxolid® BLC Implant Ø 5.5mm WB, SLActive® 16mm, Roxolid® BLC Implant Ø 6.5mm WB, SLActive® 6mm, Roxolid® BLC Implant Ø 6.5mm WB, SLActive® 8mm, Roxolid® BLC Implant Ø 6.5mm WB, SLActive® 10mm, Roxolid® BLC Implant Ø 6.5mm WB, SLActive® 12mm, Roxolid® BLC Implant Ø 6.5mm WB, SLActive® 14mm, Roxolid® BLC Implant Ø 6.5mm WB, SLActive® 16mm, Roxolid® RB/WB Variobase® C Ø 3.8mm, GH 1.5mm, TAN RB/WB Variobase® C Ø 4.5mm, GH 1.5mm, TAN WB Variobase® C Ø 5.5mm, GH 1.5mm, TAN RB/WB Healing Abutment Crown, Ø 7.5mm, GH 2.5mm, AH 2mm, Ti RB/WB Healing Abutment Crown, Ø 7.5mm, GH 2.5mm, AH 4mm, Ti RB/WB Healing Abutment Crown, Ø 7.5mm, GH 3.5mm, AH 2mm, Ti RB/WB Healing Abutment Crown, Ø 7.5mm, GH 3.5mm, AH 4mm, Ti RB/WB Immediate Temporary Abutment crown, Ø 3.8mm, GH 1.5mm, TAN RB/WB Immediate Temporary Abutment crown, Ø 3.8mm, GH 2.5mm, TAN RB/WB Immediate Temporary Abutment crown, Ø 3.8mm, GH 3.5mm, TAN RB/WB Immediate Temporary Abutment crown, Ø 4.5mm, GH 1.5mm, TAN RB/WB Immediate Temporary Abutment crown, Ø 4.5mm, GH 2.5mm, TAN RB/WB Immediate Temporary Abutment crown, Ø 4.5mm, GH 3.5mm, TAN RB/WB Temporary Abutment Ø 3.8mm, GH 1.5mm, VITA CAD-Temp®/TAN RB/WB Temporary Abutment Ø 4.5mm, GH 1.5mm, VITA CAD-Temp®/TAN WB Temporary Abutment Ø 5.5mm, GH 1.5mm, VITA CAD-Temp®/TAN ScanPost S RB/WB L TAN RB/WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN BLX/BLC Guided Implant Driver for ratchet, screw-retained, stainless steel BLX/BLC Guided Implant Driver for ratchet, stainless steel Novaloc® Impression Coping PEEK
Model Identifier(s)
10.6134 023.0033V2 25.0001 025.0073V4 025.0074V4 025.0075V4 34.291 34.292 34.293 34.294 34.295 34.296 034.299V4 34.362 34.363 34.365 34.366 34.367 34.368 34.369 34.371 34.372 34.373 035.8008S 035.8010S 035.8012S 035.8014S 035.8016S 035.8018S 035.8206S 035.8208S 035.8210S 035.8212S 035.8214S 035.8216S 035.8218S 035.8406S 035.8408S 035.8410S 035.8412S 035.8414S 035.8416S 035.8418S 035.8706S 035.8708S 035.8710S 035.8712S 035.8714S 035.8716S 035.8806S 035.8808S 035.8810S 035.8812S 035.8814S 035.9008S 035.9010S 035.9012S 035.9014S 035.9016S 035.9018S 035.9206S 035.9208S 035.9210S 035.9212S 035.9214S 035.9216S 035.9218S 035.9406S 035.9408S 035.9410S 035.9412S 035.9414S 035.9416S 035.9418S 035.9706S 035.9708S 035.9710S 035.9712S 035.9714S 035.9716S 035.9806S 035.9808S 035.9810S 035.9812S 035.9814S 035.9816S 62.4981 62.4982 62.4983 064.4234S 064.4235S 064.4236S 064.4237S 064.4322S 064.4323S 064.4324S 064.4332S 064.4333S 064.4334S 64.4361 64.4371 64.439 65.0038 65.431 65.481 66.4401 66.4404 2010.722-NOV