FDA Registration Active 🇨🇭 Switzerland

INSTITUT STRAUMANN AG

Reg #: 9613348 · FEI: 3004975279 · Expires 2026
Products
28
Proprietary Names
244
Establishment Types
3
Classifications
28

Registration Details

Registration Name
INSTITUT STRAUMANN AG
Registration Number
9613348
FEI Number
3004975279
Status
Active
Expiry Year
2026
Initial Importer
No
Address
PETER MERIAN-WEG 12
City
BASEL Basel-Stadt
Country
CH

Regulatory Submissions

510(k) Number
K061176
PMA Number
P930021

Owner / Operator

Firm Name
INSTITUT STRAUMANN AG
Operator Number
9005052
Address
PETER MERIAN-WEG 12
City
BASEL
State
CH-NOTA
Postal Code
CH-4002
Country
CH
Correspondent
Andreas Petermann

US Agent

Business Name
Straumann USA, LLC
Contact Name
Jennifer M Jackson
Address
60 Minuteman Rd
City
Andover
State
MA
ZIP
01810
Country
US
Phone
978 7472509

Products

Device Name Product Code
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Bone Grafting Material, Synthetic LYC
Powder, Porcelain EIH
Dental Abutment Design Software For Dental Laboratory PNP
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Alloy, Metal, Base EJH
Chisel, Osteotome, Surgical EMM
Barrier, Animal Source, Intraoral NPL
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
Anchor, Preformed EJX
Implant, Endosseous, Orthodontic OAT
Drill, Bone, Powered DZI
Material, Tooth Shade, Resin EBF
Bar, Preformed EHO
Forceps, Rongeur, Surgical EMH
Attachment, Precision, All EGG
Screw, Fixation, Intraosseous DZL
Bur, Dental EJL
Biologic Material, Dental NQA
Accessories, Implant, Dental, Endosseous NDP
Bone Grafting Material, Animal Source NPM
Prosthesis, Breast, External, Used With Adhesive KCZ
Crown And Bridge, Temporary, Resin EBG
Punch, Biopsy, Surgical EME
Scaler, Rotary ELB
Barrier, Synthetic, Intraoral NPK
Cleanser, Root Canal KJJ

Proprietary Names

Straumann Dental Implant System WN Gold Abutment, for Bridge RN Gold Abutment, for Bridge Straumann BoneCeramic Straumann CARES Screw-Retained Bridges and Bars Straumann 4 mm Short Implants Straumann Screw Retained Abutments Straumann PURE Ceramic Implants zerion and glass ceramic restorations NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 1, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 1, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 1, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 0, ZrO2 NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 1, ZrO2 Straumann Variobase C TLC Implants BLC Implants Straumann Roxolid SLA Implants STRAUMANN DENTAL IMPLANT SYSTEM ticon and coron restorations Straumann® Retentive System – Novaloc TiN Abutments Straumann CARES Abutments Straumann ProClean™ Cassette Straumann CARES Screw-Retained Bridge and Dolder Bar zerion HT elements STRAUMANN BONE CERAMIC STRAUMANN BONECERAMIC Roxolid BLX Implants NC Healing Abutment Straumann Variobase Abutments for Bridge/Bar Straumann Variobase for CEREC Variobase for CEREC TLX Screw-Retained Abutments RC Healing Abutment, conical RC Healing Abutment, customizable RN Healing Cap NNC Healing Cap RC Healing Abutment , bottle NC Healing Abutment, conical NC Healing Abutment, customizable WN Healing Cap NC Healing Abutment, bottle WN Closure Cap NNC Closure Cap RC Closure Cap NC Closure Cap RN Closure Cap NNC Solid Abutment NNC Temporary Coping NNC Protective Cap Bone Level Implant TiZr RC 4.8mm L 8, 10, 12, 14mm Bone Level Implant TiZr RC 4.1mm L 8,10,12, 14mm WN Temporary Abutment, VITA CAD-Temp, PMMA RN Temporary Abutment, VITA CAD-Temp, PMMA NC Temporary Abutment, VITA CAD-Temp, PMMA RC Temporary Abutment, VITA CAD-Temp, PMMA NNC Temporary Abutment, VITA CAD-Temp, PMMA Straumann Membrane Max IPS Empress CAD Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA Straumann Variobase Abutments Straumann Narrow Neck CrossFit (NNC) Closure Screws Straumann Narrow Neck CrossFit (NNC) Healing Caps Straumann Narrow Neck CrossFit (NNC) Temporary Abutments Straumann Narrow Neck CrossFit (NNC) Dental Implant System Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Crown S300W Straumann CARES Visual Chairside DWOS Straumann CARES Visual AS260 ST200E ST 300E DI-1 Smart Design SIRIOS AS200E synOcta abutment Screw Retained Abutments Straumann BLX Surgical Cassette polyamide restoration CARES TAN Abutment Straumann CARES TAN Abutment Straumann BLX Gold Abutment Straumann BLX Implant System Straumann Modular Cassette Porcelain powder Novaloc Equator Attachment Optiloc 033.561S Standard Plus TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.563S Standard Plus TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.624S Tapered Effect, TL, WN, Ø4.1mm, SLActive 14mm, TiZr 033.614S Standard Plus TL, WN Ø4.8mm, SLActive 14mm, TiZr 033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr 033.602S Standard TL, WN Ø4.8mm, SLActive 10mm, TiZr 033.582S Standard TL, RN, Ø4.8mm, SLActive 10mm, TiZr 033.592S Standard Plus TL, RN, Ø4.8mm, SLActive 10mm, TiZr 033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr 033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr 033.612S Standard Plus TL, WN Ø4.8mm, SLActive 10mm, TiZr 033.571S Tapered Effect, TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.622S Tapered Effect, TL, WN, Ø4.1mm, SLActive 10mm, TiZr 033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.593S Standard Plus TL, RN, Ø4.8mm, SLActive 12mm, TiZr 033.564S Standard Plus TL, RN, Ø4.1mm, SLActive 14mm, TiZr 033.623S Tapered Effect, TL, WN, Ø4.1mm, SLActive 12mm, TiZr 033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr 033.594S Standard Plus TL, RN, Ø4.8mm, SLActive 14mm, TiZr 033.611S Standard Plus TL, WN Ø4.8mm, SLActive 8mm, TiZr 033.573S Tapered Effect, TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.590S Standard Plus TL, RN, Ø4.8mm, SLActive 6mm, TiZr 033.583S Standard TL, RN, Ø4.8mm, SLActive 12mm, TiZr 033.601S Standard TL, WN Ø4.8mm, SLActive 8mm, TiZr 033.572S Tapered Effect, TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.610S Standard Plus TL, WN Ø4.8mm, SLActive 6mm, TiZr 033.584S Standard TL, RN, Ø4.8mm, SLActive 14mm, TiZr 033.562S Standard Plus TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.580S Standard TL, RN, Ø4.8mm, SLActive 6mm, TiZr 033.613S Standard Plus TL, WN Ø4.8mm, SLActive 12mm, TiZr 033.581S Standard TL, RN, Ø4.8mm, SLActive 8mm, TiZr 033.603S Standard TL, WN Ø4.8mm, SLActive 12mm, TiZr 033.574S Tapered Effect, TL, Ø4.1mm, SLActive 14mm, TiZr 033.600S Standard TL, WN Ø4.8mm, SLActive 6mm, TiZr 033.591S Standard Plus TL, RN, Ø4.8mm, SLActive 8mm, TiZr Straumann Variobase for Crown AS Neodent Titanium Block for Medentika Holder Straumann Pre-Milled Abutment Blank for Medentika Holder Straumann InLab Validated Workflow TLX Implant System NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type A NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type A NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type A NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type B NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type B NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type B NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type A NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type B Strauamnn CARES Dolder Bar Titanium Straumann CARES Screw-retained Bridge Titanium Straumann CARES CS2 Scanner CARES Abutment MEMFIX Straumann PUREloc Abutments Straumann Bone Level Tapered Implant RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B Screw-Retained Abutments NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B Narrow Neck CrossFit (NNC) Gold Abutment for Bridges STRAUMANN EMDOGAIN Straumann® RidgeFit Implants Straumann Anatomic Healing Abutments Pre-milled Abutment Blank for CARES® NNC Cementable Abutment, 15 degree angle Type A NNC Cementable Abutment, 15 degree angle Type B NNC Cementable Abutment, straight NNC Basel Screw for Cementable Abutments NNC Closure Screw, H0 (4-pack) RC Healing Abutment, conical diameter 6, H4 NC Closure Cap for Fixation Cap, Ti RC Healing Abutment, conical diameter 6, H6 RN Closure Cap, H1.5, Ti (4-pack) NNC Closure Screw, H0 RC Closure Screw, H0 RC Healing Abutment, conical diameter 4.5, H6 NC Fixation Cap, Ti NC Closure & Fixation Cap, diameter 5.5mm, Ti RC Closure & Fixation Cap, diameter 5.5mm, Ti RC Closure Screw, H0 (4-pack) RC Closure Cap for Fixation Cap, Ti NC Closure Screw, H0 (4-pack) RC Closure Screw, H0.5 RC Closure Screw, H0.5 (4-pack) RC Fixation Cap, Ti RN closure Cap, H0, Ti (4-pack) NNC Closure Screw, H0.5 (4-pack) RC Healing Abutment, conical diameter 4.5, H4 NNC Closure Screw, H0.5 NC Closure Screw, H0 NC Closure Screw, H0.5 (4-pack) RC Healing Abutment, conical diameter 4.5, H2 NC Closure Screw, H0.5 RC Healing Abutment, conical diameter 6, H2 Taper Effect Roxolid Dental Implant Accesories n!ce Crown n!ce Inlay n!ce Partial Crown n!ce Veneer n!ce Onlay Straumann XenoGraft Variobase® XC for Bridge/Bar, Variobase® XC for Bridge/Bar AS Straumann Custom Abutment AS STRAUMANN EXTRAORAL IMPLANT SYSTEM polycon ae restoration NC Variobase™ Abutments, with screw, D 3.8mm, H 3.5mm, TAN NC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TAN NNC Variobase™ Abutments, with screw, D 3.9mm, H 3.75mm, TAN RC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TAN WN Variobase™ Abutments, with screw, D 7mm, H 4.5mm, TAN RC Variobase™ Abutments, with screw, D 4.5mm, 3.5mm, TAN WN Variobase®, for crown, with screw, D 7mm, H 6.5mm, TAN RN Variobase™ Abutments, with screw, D 55mm, H 4mm, TAN NNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TAN RN Variobase®, for crown, with screw, D 55mm, H 6mm, TAN Straumann TiBrush Straumann Ceramic Healing Abutments BLT 4.8 RC, SLActive 18mm, TiZr, Loxim BLT 3.3mm NC, SLA 18mm, TiZr, Loxim BLT 3.3 NC, SLActive 18mm, TiZr, Loxim BLT 4.8mm RC, SLA 18mm, TiZr, Loxim BLT 4.1mm RC, SLA 18mm, TiZr, Loxim BLT 4.1 RC, SLActive 18mm, TiZr, Loxim Synthetic Barrier, intraoral MembraGel SRBB Bone Level NNC Variobase Abutment, with screw, D 55mm, H 4mm, TAN NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN RN Variobase Abutment, with screw, D 55mm, H 4mm, TAN RC Variobase Abutment, with screw, D 4.5mm, 3.5mm, TAN WN Variobase Abutment, with screw, D 7mm, H 4.5mm, TAN n!ce® for Planmill RC Temporary Abutment Straumann BLX 3.5 mm Implants Straumann CARES Visual and Nova Dental CAD RB/WB Screw-retained abutment, angled 17° & 30°, 4.6mm BLC Implant 3.75mm RB, SLA® 18mm, Roxolid® BLC Implant 3.75mm RB, SLActive® 18mm, Roxolid® NC GOLD ABUTMENT FOR CROWNS Straumann TLC Implants Straumann BLC Implants Straumann Immediate Temporary Abutments Straumann® PrefGel

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device