Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011148229

FEI Number

3011148229

Entity Name

EDELWEISSDR AG

City/State/Country

Zug, CH

Establishment Address

Unter Altstadt 28, Mercandor, Zug 6300, CH

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

EdelweissDR AG (Owner Number: 10047324)

Owner / Operator Contact Address

Unter Altstadt 28, Mercandor, Zug, CH-ZG 6300, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080480

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-08-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2014-08-08

Official Correspondent

Manuela Brusoni

US Agent Details

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

Related Public Records

Same Entity

EdelweissDR AG

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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
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
3027584973	F & A LABORATORIO FARMACEUTICO LTDA	Sao Paulo-SP, BR
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011148229. Last updated year: 2026. Please use registration number 3011148229 when referencing this establishment in official correspondence.