FRASACO GMBH

FDA Device Registration & Listing · TETTNANG Baden-Wurttemberg, DE · Registration 8010339

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8010339
FEI Number
3003053568
Entity Name
FRASACO GMBH
City/State/Country
TETTNANG Baden-Wurttemberg, DE
Establishment Address
OBERHOFER STRASSE 18, TETTNANG Baden-Wurttemberg D-88069, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FRASACO GMBH (Owner Number: 9032384)
Owner / Operator Contact Address
OBERHOFER STRASSE 18, --, TETTNANG, DE-NOTA D-88069, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

STRIP CROWN FORMS MATRIX BANDS WEKII FOOT SUPPORT PLASTOSAN FOOT SUPPORT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELZ Crown, Preformed Dental Class 1 872.3330 1996-12-05
DZN Instruments, Dental Hand Dental Class 1 872.4565 1996-12-05
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2002-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

Brad Wilkinson Email: bwilkinson@practicon.com Phone: (252) 7525183

Related Public Records

Same Entity

FRASACO GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3025769679 RB DENTAL Seoul, KR
3006007013 PARK-ISTRE, LLC. DALLAS, TX, US
3016564992 DENTAC LLC North Miami, FL, US
3042903603 CERLUCENT, LLC Norwalk, CA, US
3027989276 NORTHWEST DENTAL Hartland, WI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010339. Last updated year: 2026. Please use registration number 8010339 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.