Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005347791

FEI Number

3005347791

Entity Name

ADM, a.s.

City/State/Country

Brno Mesto Brno, CZ

Establishment Address

U Vodarny 2, Brno Mesto Brno 61600, CZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADM, a.s. (Owner Number: 9077377)

Owner / Operator Contact Address

U Vodarny 2, Brno, CZ-642 61600, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K952353

PMA Number

N/A

All Registered Proprietary Names

Dentapreg UFM Dentapreg VEIL Dentapreg BRAID Dentapreg PINPost Dentapreg PFM Dentapreg PFU Dentapreg SFM Dentapreg BUNDLE Dentapreg SFU Dentapreg MESH DENTAPREG Dentapreg INTRO Dentapreg STARTER KIT Dentapreg MESH Economy Pack Fibrafill CUBE Fibrafill DENTIN Fibrafill FLOW

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2005-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

Martina Spisakova Email: spisakova@dentapreg.com Phone: (347) 2654814

Related Public Records

Same Entity

ADM, a.s.

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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005347791. Last updated year: 2026. Please use registration number 3005347791 when referencing this establishment in official correspondence.