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
- [email protected]
- Phone
- 978 7472509
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2008-01-09 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2011-05-19 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2021-12-14 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2008-02-20 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2021-03-22 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-07-29 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2008-03-12 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 1999-07-02 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2014-08-21 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2008-01-24 |
| Anchor, Preformed | EJX | Class 1 | Dental | No | 2011-05-19 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2008-01-09 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2011-05-19 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2010-01-07 |
| Bar, Preformed | EHO | Class 1 | Dental | No | 2011-05-19 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2011-05-19 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2021-08-03 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 1999-03-10 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2011-05-19 |
| Biologic Material, Dental | NQA | Class 3 | Dental | No | 2006-12-06 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2007-06-29 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2014-08-21 |
| Prosthesis, Breast, External, Used With Adhesive | KCZ | Class 1 | General, Plastic Surgery | No | 2007-06-29 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2010-01-07 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2011-05-19 |
| Scaler, Rotary | ELB | Class 2 | Dental | No | 2011-09-16 |
| Barrier, Synthetic, Intraoral | NPK | Class 2 | Dental | No | 2010-01-07 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2007-12-11 |
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