GESTENCO INTERNATIONAL AB

FDA Device Registration & Listing · GOTEBORG Vastra Gotaland, SE · Registration 3004109528

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
3004109528
FEI Number
3004109528
Entity Name
GESTENCO INTERNATIONAL AB
City/State/Country
GOTEBORG Vastra Gotaland, SE
Establishment Address
FRIDKULLAGATAN 14, GOTEBORG Vastra Gotaland SE 412 62, SE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Gestenco International AB (Owner Number: 9028524)
Owner / Operator Contact Address
14 Fridkullagatan, --, Gothenburg, SE-NOTA SE 412 62, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Plucker Aligner Remover Rodneys Aligner Seaters

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BRW Protector, Dental Anesthesiology Class 1 868.5820 2010-12-07
DZN Instruments, Dental Hand Dental Class 1 872.4565 2023-05-02
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-12-05
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2021-04-30

Official Correspondent

Matteo Catenacci

US Agent Details

Elisa Maldonado-Holmertz Business: Obelix Consulting Email: elisamh@obelixconsult.com Phone: (512) 4316069

Related Public Records

Same Entity

Gestenco International AB
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
K161684 Reliance Orthodontic Products, Inc. Quantum LB 2016-10-06
K810210 Sci-Pharm, Inc. MAGIC-TOUCH 1981-02-10
K875144 Reliance Orthodontic Products, Inc. EXCEL FAST SET 1988-02-26
K894358 Ormco Corp. LUMINA ORTHODONTIC BRACKET 1989-09-15
K925012 American Orthodontics PLASTIC CHAIN 1993-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004109528. Last updated year: 2026. Please use registration number 3004109528 when referencing this establishment in official correspondence.
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