Sirona Dental Systems Gmbh
⚠️ Moderate Risk
FEI: 3003719498 • Bensheim, Hassia • GERMANY
FEI Number
3003719498
Location
Bensheim, Hassia
Country
GERMANYAddress
Fabrikstr. 31, , Bensheim, Hassia, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
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.
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 |
|---|---|---|---|
| 7/28/2023 | 76PKJCROWN & BRIDGE MATERIAL, RESIN BASED | Division of Southeast Imports (DSEI) | |
| 4/20/2022 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Division of Northern Border Imports (DNBI) | |
| 9/30/2020 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 3/17/2017 | 76EFBHANDPIECE, AIR-POWERED, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 76EGSHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 76EIHPOWDER, PORCELAIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 76EGDWAX, DENTAL, INTRAORAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 76EJLBUR, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 90MUHSYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 76EAPUNIT, X-RAY, INTRAORAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 76EFBHANDPIECE, AIR-POWERED, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2017 | 76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2015 | 90OASX-RAY, TOMOGRAPHY, COMPUTED, DENTAL | Division of Southeast Imports (DSEI) | |
| 6/3/2015 | 90OASX-RAY, TOMOGRAPHY, COMPUTED, DENTAL | Division of Southeast Imports (DSEI) | |
| 6/3/2015 | 76EIHPOWDER, PORCELAIN | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/30/2013 | 76EKZUNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL | New Orleans District Office (NOL-DO) | |
| 2/7/2011 | 90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | New York District Office (NYK-DO) | |
| 5/21/2009 | 76OFWRESTORATIVE INSTRUMENT AND COMPONENT TRAY | New Orleans District Office (NOL-DO) | |
| 7/13/2006 | 76LTESYSTEM, TOOTH IMPLANT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/22/2004 | 76EAYLIGHT, FIBER OPTIC, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/22/2004 | 76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sirona Dental Systems Gmbh's FDA import refusal history?
Sirona Dental Systems Gmbh (FEI: 3003719498) has 22 FDA import refusal record(s) in our database, spanning from 11/22/2004 to 7/28/2023.
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. Sirona Dental Systems Gmbh's FEI number is 3003719498.
What types of violations has Sirona Dental Systems Gmbh received?
Sirona Dental Systems Gmbh has been cited for 5 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 Sirona Dental Systems Gmbh come from?
All FDA import refusal data for Sirona Dental Systems 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.