D B Orthodontics Ltd.
⚠️ Moderate Risk
FEI: 3004730002 • Silsden Keighley, West Yorkshire • UNITED KINGDOM
FEI Number
3004730002
Location
Silsden Keighley, West Yorkshire
Country
UNITED KINGDOMAddress
Ryefield Way, , Silsden Keighley, West Yorkshire, United Kingdom
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZDTUBE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZDTUBE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZDTUBE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZDTUBE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZDTUBE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZCWIRE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZCWIRE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZCWIRE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZDTUBE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/24/2021 | 76DZDTUBE, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 9/8/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is D B Orthodontics Ltd.'s FDA import refusal history?
D B Orthodontics Ltd. (FEI: 3004730002) has 36 FDA import refusal record(s) in our database, spanning from 9/8/2015 to 2/24/2021.
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. D B Orthodontics Ltd.'s FEI number is 3004730002.
What types of violations has D B Orthodontics Ltd. received?
D B Orthodontics Ltd. 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 D B Orthodontics Ltd. come from?
All FDA import refusal data for D B Orthodontics Ltd. 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.