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Straumann Straumann® Surgical Instruments and Auxiliaries - HSA Registration DE0506592

Access comprehensive regulatory information for Straumann Straumann® Surgical Instruments and Auxiliaries in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506592 and owned by Institut Straumann AG. The device was registered on January 24, 2022.

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
DE0506592
Straumann Straumann® Surgical Instruments and Auxiliaries
HSA Registration Number: DE0506592
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Product Description

Straumann® non-sterile surgical instruments and auxiliaries are intended for planning, osteotomy reparation before implant placement or placement of implants or prosthetics of the Straumann® Dental Implant System. Straumann® sterile surgical instruments and auxiliaries are intended to be used in osteotomy preparation. Straumann® sterile and non- sterile surgical instruments and auxiliaries are indicated for use in dental procedures aiming to place implants or prosthetics of the Straumann® Dental Implant System in fully or partially edentulous patients.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0506592
Registration Date
January 24, 2022
Change Notification Approval Date
October 09, 2024
Retention Due Date
January 23, 2026
Product Owner
Short Name
Institut Straumann
Address
Peter Merian-Weg 12, 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)
BL/BLT Guided Adapter for handpiece, L 24mm, stainless steel BLT Profile Drill, short, FIBA compatible Ø 3.3mm, L 27mm, stainless steel BLT Profile Drill, short, FIBA compatible Ø 4.1mm, L 27mm, stainless steel BLT Profile Drill, short, FIBA compatible Ø 4.8mm, L 27mm,stainless steel BL/NNC Profile Drill, short, FIBA compatible Ø 3.3mm, L 28mm, stainless steel BL Profile Drill,short, FIBA compatible Ø 4.1mm, L 28mm, stainless steel BL Profile Drill, short, FIBA compatible Ø 4.8mm, L 28mm, stainless steel SP Profile Drill, RN, short, FIBA compatible Ø 3.3mm, L 25mm, stainless steel SP Profile Drill, RN, short, FIBA compatible Ø 4.1mm, L 25mm, stainless steel BLT Tap, short, FIBA compatible Ø 3.3mm, L 21mm, stainless steel BLT Tap, short, FIBA compatible Ø 4.1mm, L 21mm, stainless steel BLT Tap, short, FIBA compatible Ø 4.8mm, L 21mm, stainless steel BL/NNC Tap, short, FIBA compatible Ø 3.3mm, L 22mm, stainless steel BL Tap, short, FIBA compatible Ø 4.1mm, L 22mm, stainless steel BL Tap, short, FIBA compatible Ø 4.8mm, L 22mm, stainless steel S/SP Tap, short, FIBA compatible Ø 3.3mm, L 22mm, stainless steel S/SP Tap, short, FIBA compatible Ø 4.1mm, L 22mm, stainless steel S/SP Tap, short, FIBA compatible Ø 4.8mm, L 22mm, stainless steel Guided Adapter for Profile Drill, FIBA, H2, handpiece, stainless steel Guided Adapter for Profile Drill, FIBA, H4, handpiece, stainless steel Guided Adapter for Profile Drill, FIBA, H6, handpiece, stainless steel Guided Adapter for Tap, FIBA, H2, handpiece, stainless steel Guided Adapter for Tap, FIBA, H4, handpiece, stainless steel Guided Adapter for Tap, FIBA, H6, handpiece, stainless steel Adapter for handpiece, shortfor surgical handle, L 26mm, stainless steel RT Profile Drill, short, for implants Ø 3.75/Ø4.8mm, stainless steel RT Profile Drill, long, for implants Ø 3.75/Ø4.8mm, stainless steel WT Profile Drill, short, for implants Ø 5.5/Ø6.5mm, stainless steel WT Profile Drill, long, for implants Ø 5.5/Ø6.5mm, stainless steel Drill Stop Set, Type A, for drill Ø 2.2 - 4.2mm, short 12mm Drill Stop Set, Type B, for drill Ø 2.2 - 4.2mm, short 10mm Drill Stop Set, Type C, for drill Ø 2.2 - 4.2mm, short 8mm Drill Stop Set, Type D, for drill Ø 2.2 - 4.2mm, short 6mm Drill Stop Set, Type E, for drill Ø 2.2 - 4.2mm, short 4mm Drill Stop Set, Type A wide, for drill Ø 4.7 - 6.2mm, short 12mm Drill Stop Set, Type B wide, for drill Ø 4.7 - 6.2mm, short 10mm Drill Stop Set, Type C wide, for drill Ø 4.7 - 6.2mm, short 8mm Drill Stop Set, Type D wide, for drill Ø 4.7 - 6.2mm, short 6mm Drill Stop Set, Type E wide, for drill Ø 4.7 - 6.2mm, short 4mm SP/NNC/TE Guided Adapter for handpiece, L 23mm, stainless steel S Guided Adapter for handpiece, L 24mm, stainless steel
Model Identifier(s)
26.0083 34.324 34.325 34.326 34.327 34.328 34.329 34.332 34.333 34.345 34.346 34.347 34.348 34.349 34.35 34.351 34.352 34.353 34.354 34.355 34.356 34.357 34.358 34.359 34.361 36.33 36.3301 36.3302 36.3303 040.584S 040.585S 040.586S 040.587S 040.588S 040.589S 040.590S 040.591S 040.592S 040.593S 46.708 46.709