SPT ROTH LTD.

FDA Device Registration & Listing · LYSS Bern, CH · Registration 9616044

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
9616044
FEI Number
3002336796
Entity Name
SPT ROTH LTD.
City/State/Country
LYSS Bern, CH
Establishment Address
WERKSTRASSE 28, LYSS Bern 3250, CH
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SPT ROTH LTD. (Owner Number: 9043481)
Owner / Operator Contact Address
Werkstrasse 28, Lyss, CH-BE CH-3250, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K110335
PMA Number
N/A

All Registered Proprietary Names

Clarity SL Clarity Advanced Ceramic Brackets ceramic, orthodontic bracket

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2011-01-05
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2011-03-01
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2016-07-26

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

SPT ROTH LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180404 3M Healthcare 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 2018-03-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616044. Last updated year: 2026. Please use registration number 9616044 when referencing this establishment in official correspondence.
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