FDA Registration Active 🇨🇭 Switzerland

Straumann Villeret SA

Reg #: 9614404 · FEI: 3002807318 · Expires 2026
Products
15
Proprietary Names
170
Establishment Types
1
Classifications
15

Registration Details

Registration Name
Straumann Villeret SA
Registration Number
9614404
FEI Number
3002807318
Status
Active
Expiry Year
2026
Initial Importer
No
Address
LES CHAMPS DU CLOS 2
City
VILLERET Bern
Country
CH

Regulatory Submissions

510(k) Number
K070478

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
Bar, Preformed EHO
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Dental Abutment Design Software For Dental Laboratory PNP
Bur, Dental EJL
Implant, Endosseous, Orthodontic OAT
Prosthesis, Breast, External, Used With Adhesive KCZ
Forceps, Rongeur, Surgical EMH
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Accessories, Implant, Dental, Endosseous NDP
Punch, Biopsy, Surgical EME
Screw, Fixation, Intraosseous DZL
Chisel, Osteotome, Surgical EMM
Drill, Bone, Powered DZI
Anchor, Preformed EJX

Proprietary Names

Straumann Dental Implant System Screw Retained Abutments RC Temporary Abutment Straumann CARES Abutments Straumann PURE Ceramic Implants Straumann Variobase for Crown AS STRAUMANN DENTAL IMPLANT SYSTEM synOcta abutment Pre-milled Abutment Blank for CARES® NC GOLD ABUTMENT FOR CROWNS Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA NC Healing Abutment TLX Screw-Retained Abutments WN Gold Abutment, for Bridge RN Gold Abutment, for Bridge Neodent Titanium Block for Medentika Holder Straumann Pre-Milled Abutment Blank for Medentika Holder Straumann InLab Validated Workflow 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 Straumann PUREloc Abutments SRBB Bone Level 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 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 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 BLX Gold Abutment 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 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 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 Roxolid BLX Implants 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 EXTRAORAL IMPLANT SYSTEM Straumann Variobase Abutments for Bridge/Bar Straumann 4 mm Short Implants Straumann Variobase C Straumann Screw Retained Abutments Dental Implant Accesories 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 Bone Level Tapered Implant Straumann Variobase Abutments TLX Implant System MEMFIX Straumann BLX 3.5 mm Implants Narrow Neck CrossFit (NNC) Gold Abutment for Bridges Bone Level Implant TiZr RC 4.8mm L 8, 10, 12, 14mm Bone Level Implant TiZr RC 4.1mm L 8,10,12, 14mm Straumann Roxolid SLA Implants Straumann CARES Screw-Retained Bridges and Bars 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 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 Straumann Modular Cassette Taper Effect Roxolid Straumann BLX Implant System 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 Straumann Immediate Temporary Abutments Straumann TLC Implants Straumann BLC Implants Straumann Anatomic Healing Abutments NNC Solid Abutment NNC Temporary Coping NNC Protective Cap Straumann Variobase for CEREC Variobase for CEREC Strauamnn CARES Dolder Bar Titanium Straumann CARES Screw-retained Bridge Titanium Straumann® Retentive System – Novaloc TiN Abutments Variobase® XC for Bridge/Bar, Variobase® XC for Bridge/Bar AS TLC Implants BLC Implants

Establishment Types

Manufacture Medical Device