Straumann USA, LLC

FDA Device Registration & Listing · ANDOVER, MA, US · Registration 1222315

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1222315
FEI Number
1000121052
Entity Name
Straumann USA, LLC
City/State/Country
ANDOVER, MA, US
Establishment Address
60 MINUTEMAN RD., ANDOVER, MA 01810, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
INSTITUT STRAUMANN AG (Owner Number: 9005052)
Owner / Operator Contact Address
PETER MERIAN-WEG 12, BASEL, CH-NOTA CH-4002, CH
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K243278
PMA Number
N/A

All Registered Proprietary Names

Neodent Titanium Block for Medentika Holder Straumann Pre-Milled Abutment Blank for Medentika Holder Straumann InLab Validated Workflow Straumann Custom Abutment AS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2025-03-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-03-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-03-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INSTITUT STRAUMANN AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010377510 DENTAL WINGS GMBH Chemnitz Saxony, DE
3007130440 ClearCorrect , LLC Round Rock, TX, US
3026444199 Medentika GmbH Calw Baden-Wurttemberg, DE
3007218081 Straumann Villeret SA Corgemont Bern, CH
3005106408 etkon GMBH GRAEFELFING, BAVARIA, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222315. Last updated year: 2026. Please use registration number 1222315 when referencing this establishment in official correspondence.
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