VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
✅ Low Risk
FEI: 4838 • Bad Sackingen, Baden-wurttemberg • GERMANY
FEI Number
4838
Location
Bad Sackingen, Baden-wurttemberg
Country
GERMANYAddress
Spitalgasse 3, , Bad Sackingen, Baden-wurttemberg, Germany
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/23/2021 | 76EIHPOWDER, PORCELAIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/1/2010 | 76EJBHANDLE, INSTRUMENT, DENTAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 6/19/2006 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/19/2006 | 76EIHPOWDER, PORCELAIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/19/2006 | 76LTESYSTEM, TOOTH IMPLANT | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.'s FDA import refusal history?
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. (FEI: 4838) has 5 FDA import refusal record(s) in our database, spanning from 6/19/2006 to 4/23/2021.
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. VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.'s FEI number is 4838.
What types of violations has VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. received?
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. has been cited for 2 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 VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. come from?
All FDA import refusal data for VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. 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.