Coltene /Whaledent AG

⚠️ Moderate Risk

FEI: 3002806620 • Altstatten Sg, Saint Gall • SWITZERLAND

FEI

FEI Number

3002806620

📍

Location

Altstatten Sg, Saint Gall

🇨🇭

Country

SWITZERLAND

🏢

Address

Feldwiesenstrasse 20, , Altstatten Sg, Saint Gall, Switzerland

Moderate Risk

FDA Import Risk Assessment

37.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/18/2023

Latest Refusal

6/10/2005

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

28.8×30%

Recency

40.8×20%

Frequency

2.7×10%

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

1184×

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).

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

3411×

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
10/18/2023	76KLEAGENT, TOOTH BONDING, RESIN	118NOT LISTED 3280FRNMFGREG	Division of Northeast Imports (DNEI)
11/18/2022	76EBFMATERIAL, TOOTH SHADE, RESIN	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
10/25/2013	76EBFMATERIAL, TOOTH SHADE, RESIN	2480RXPERSONAL	New Orleans District Office (NOL-DO)
4/1/2010	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED	Seattle District Office (SEA-DO)
6/10/2005	76EMACEMENT, DENTAL	118NOT LISTED	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Coltene /Whaledent AG's FDA import refusal history?

Coltene /Whaledent AG (FEI: 3002806620) has 5 FDA import refusal record(s) in our database, spanning from 6/10/2005 to 10/18/2023.

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. Coltene /Whaledent AG's FEI number is 3002806620.

What types of violations has Coltene /Whaledent AG received?

Coltene /Whaledent AG has been cited for 4 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 Coltene /Whaledent AG come from?

All FDA import refusal data for Coltene /Whaledent AG 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.