Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004070020

FEI Number

3004070020

Entity Name

OSSTELL AB

City/State/Country

GOTEBORG Vastra Gotaland, SE

Establishment Address

Stampgaten 14, GOTEBORG Vastra Gotaland 41101, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSSTELL AB (Owner Number: 9059818)

Owner / Operator Contact Address

Stampgaten 14, --, GOTEBORG, SE-NOTA 41101, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132401

PMA Number

N/A

All Registered Proprietary Names

Smart Pegs Type 1-111 SmartPeg Type 117, 127, 137 OsstellConnect SmartPeg Types 1- 111 SmartPeg Type 117, 127, 137 Smart Pegs Type 1-111

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	2015-03-16
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2019-01-11
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2014-04-10

Official Correspondent

Stellan Sundstrom

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

OSSTELL 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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9614866	ADVANCED TECHNOLOGY RESEARCH S.R.L.	PISTOIA, IT
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 3004070020. Last updated year: 2026. Please use registration number 3004070020 when referencing this establishment in official correspondence.