Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013206323

FEI Number

3013206323

Entity Name

INTEGRATION DIAGNOSTICS SWEDEN AB

City/State/Country

Goteborg Vastra Gotaland, SE

Establishment Address

Furstenbergsgatan 4, Goteborg Vastra Gotaland 41664, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Integration Diagnostics Sweden AB (Owner Number: 10054105)

Owner / Operator Contact Address

Furstenbergsgatan 4, Goteborg, SE-O 41664, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143445

PMA Number

N/A

All Registered Proprietary Names

Osseo 100+ IS3 MulTipeg Driver MulTipeg Penguin RFA Osseo 100 MDI MulTipeg Penguin II Penguin MDI Locking screwdriver IS4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2017-02-11

Official Correspondent

Annika Hallberg

US Agent Details

Sean Kaufman Business: NSK America Corporation Email: nskqa@nskdental.com Phone: (888) 6751675

Related Public Records

Same Entity

Integration Diagnostics Sweden 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
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21

Similar Registrations

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3001082453	SWEDEN & MARTINA S.P.A.	Due Carrare Padova, IT
3025873468	WELL MEDICAL	Incheon, KR
3017604	ASEPTICO, INC.	WOODINVILLE, WA, US
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013206323. Last updated year: 2026. Please use registration number 3013206323 when referencing this establishment in official correspondence.