W&H DENTALWERK BUERMOOS GMBH

⚠️ Moderate Risk

FEI: 3003755849 • BUERMOOS, Salzburg • AUSTRIA

FEI

FEI Number

3003755849

📍

Location

BUERMOOS, Salzburg

🇦🇹

Country

AUSTRIA

🏢

Address

Ignaz Glaser Strase 53, 53 IGNAZ-GLASER-STRASSE, BUERMOOS, Salzburg, Austria

Moderate Risk

FDA Import Risk Assessment

41.8

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/30/2008

Latest Refusal

12/19/2003

Earliest Refusal

Score Breakdown

Violation Severity

55.5×40%

Refusal Volume

49.7×30%

Recency

0.0×20%

Frequency

46.3×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

50820×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

11811×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3419×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
6/30/2008	76EIFACCESSORIES, RETRACTOR, DENTAL	118NOT LISTED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/26/2006	76EKDINSTRUMENT, CUTTING, OPERATIVE	118NOT LISTED	New York District Office (NYK-DO)
8/27/2005	80LEYSET, ORAL AMINISTRATION	508NO 510(K)	Los Angeles District Office (LOS-DO)
12/19/2003	76EFAHANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is W&H DENTALWERK BUERMOOS GMBH's FDA import refusal history?

W&H DENTALWERK BUERMOOS GMBH (FEI: 3003755849) has 21 FDA import refusal record(s) in our database, spanning from 12/19/2003 to 6/30/2008.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. W&H DENTALWERK BUERMOOS GMBH's FEI number is 3003755849.

What types of violations has W&H DENTALWERK BUERMOOS GMBH received?

W&H DENTALWERK BUERMOOS GMBH has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about W&H DENTALWERK BUERMOOS GMBH come from?

All FDA import refusal data for W&H DENTALWERK BUERMOOS GMBH is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.