Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680216

FEI Number

3001697513

Entity Name

FITTYDENT INTL. GMBH

City/State/Country

Vienna Wien, AT

Establishment Address

Carlbergergasse 38, Unit 3/1st floor, Vienna Wien 1230, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FITTYDENT INT. GMBH (Owner Number: 9007246)

Owner / Operator Contact Address

Carlberggasse 38/3/1, --, Vienna, AT-NOTA A-1230, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROFAST DENTURE ADH Secure Denture Strips Naturdent Denture Adhesive Secure Denture Adhesive PROFAST DENTURE CLEANSER Secure Denture Cleanser Secure orthodontic Cleansing Tablets PROFAST DENTURE CLEANER Secure Denture Adhesive PROFAST ADHESIVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOQ	Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)	Dental	Class 1	872.3410	1993-01-31
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2001-04-26
KOO	Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt	Dental	Class 1	872.3490	2001-04-26

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

FITTYDENT INT. GMBH

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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

Similar Registrations

Registration Number	Establishment Name	Location
3012187973	JERSEY DENTAL SUPPLIES	Lakewood, NJ, US
3008887731	TRIBEST DENTAL PRODUCTS CO LTD	Yangzhong Jiangsu, CN
3005699251	PASINI LABORATORIO CHIMICO S.N.C.	Burago Di Molgora Lombardy, IT
3033011342	SHANGHAI MU PROMOTIONS CO., LTD.	Shanghai, CN
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680216. Last updated year: 2026. Please use registration number 9680216 when referencing this establishment in official correspondence.