Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009117991

FEI Number

3009117991

Entity Name

EDELWEISS DENTISTRY PRODUCTS GMBH

City/State/Country

Wolfurt Vorarlberg, AT

Establishment Address

Dammstrasse 68, Wolfurt Vorarlberg 6922, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

edelweiss dentistry products gmbh (Owner Number: 10036346)

Owner / Operator Contact Address

Dammstrasse 68, Wolfurt, AT-8 6922, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241131

PMA Number

N/A

All Registered Proprietary Names

edelweiss CAD/CAM C-BLOCK A3 (10/12/16) Ceramir CAD/CAM T-BLOCK Universal Enamel edelweiss CAD/CAM i-BLOCK (øS) A1 Ceramir CAD/CAM i-BLOCK (øS) A0 Ceramir CAD/CAM i-BLOCK (øL) A1 Ceramir CAD/CAM i-BLOCK (øS) A1 edelweiss CAD/CAM i-BLOCK (øS) A0 Ceramir CAD/CAM C-BLOCK A1 edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18) edelweiss CAD/CAM C-BLOCK A1 (10/12/16) Ceramir CAD/CAM i-BLOCK (øL) A2 edelweiss CAD/CAM C-BLOCK A2 (10/12/16) edelweiss CAD/CAM C-BLOCK A3 (12/14/18) edelweiss CAD/CAM i-BLOCK (øL) A2 Ceramir CAD/CAM i-BLOCK (øS) A3 edelweiss CAD/CAM i-BLOCK (øL) Universal Enamel Ceramir CAD/CAM i-BLOCK (øL) A0 edelweiss CAD/CAM i-BLOCK (øL) A3 edelweiss CAD/CAM i-BLOCK (øS) A2 Ceramir CAD/CAM C-BLOCK A2 edelweiss CAD/CAM C-BLOCK A0 (10/12/16) edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16) Ceramir CAD/CAM i-BLOCK (øL) A3 edelweiss CAD/CAM i-BLOCK (øL) A0 edelweiss CAD/CAM C-BLOCK A0 (12/14/18) edelweiss CAD/CAM C-BLOCK A2 (12/14/18) edelweiss CAD/CAM C-BLOCK A1 (12/14/18) Ceramir CAD/CAM i-BLOCK (øS) Universal Enamel edelweiss CAD/CAM i-BLOCK (øS) Universal Enamel Ceramir CAD/CAM i-BLOCK (øS) A2 Ceramir CAD/CAM i-BLOCK (øL) Universal Enamel Ceramir CAD/CAM C-BLOCK A0 edelweiss CAD/CAM i-BLOCK (øS) A3 edelweiss CAD/CAM i-BLOCK (øL) A1 Ceramir CAD/CAM C-BLOCK A3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-05-15
ELR	Post, Root Canal	Dental	Class 1	872.3810	2018-05-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-10-30

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

edelweiss dentistry products 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
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.).

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9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE
3011808221	NOVA IMPLANTS LTD	Or-Yehuda Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009117991. Last updated year: 2026. Please use registration number 3009117991 when referencing this establishment in official correspondence.