Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030870

FEI Number

3006944200

Entity Name

DENTATUS AB

City/State/Country

SPANGA Stockholm, SE

Establishment Address

Finspangsgatan 42, SPANGA Stockholm SE-163 53, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DENTATUS AB (Owner Number: 8030870)

Owner / Operator Contact Address

FINSPANGSGATAN 42, ---, SPANGA, SE-NOTA SE-163 53, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Per-io-Tor Tips EVA Tips LTA Lamineer Tips FD Dentatus Diamond Instruments AEE Facebow AEB Facebow AEV Facebow AEC Facebow AEP Facebow AEK Facebow Profin-By-Hand Profin/EVA Profinet CePo Pilot drills Surtex Classic Aztec Twin Luscent Luscent-R Classic Sterile Surtex Luscent MEC ARH ARD ARL/P Maaxloc ARL RUG RUH RSA RSG RSC RUB RUF RUA RSI RSB RSH RUD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHL	Point, Abrasive	Dental	Class 1	872.6010	2004-02-25
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	1981-06-22
KCR	Facebow	Dental	Class 1	872.3220	1981-06-22
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2004-02-25
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2009-02-09
EJL	Bur, Dental	Dental	Class 1	872.3240	2009-04-20
ELR	Post, Root Canal	Dental	Class 1	872.3810	1981-06-22
JEP	Retainer, Matrix	Dental	Class 1	872.4565	1981-06-22
EJP	Articulators	Dental	Class 1	872.3150	1981-06-22
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2004-02-25

Official Correspondent

Mikael Skoglund

US Agent Details

Thomas Murphy Business: Dentatus USA Ltd Email: tmurphy@dentatus.com Phone: (212) 4811010

Related Public Records

Same Entity

DENTATUS 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
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08

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3030515618	Amann Girrbach AG	Maeder Vorarlberg, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030870. Last updated year: 2026. Please use registration number 8030870 when referencing this establishment in official correspondence.