Who makes Crown Down
Crown Down is a registered brand of Stomatotech Inc., a Canadian medical device company. The Crown Down Surgical Drilling Kit is a Class I medical device under EU MDR 2017/745 and is placed on the EU market through an appointed EU Authorized Representative.
Legal manufacturer
Stomatotech Inc.
4919 Boulevard Saint-CharlesPierrefonds, Quebec
H9H 3E4
Canada
All complaints, incident reports, and quality-system inquiries are handled by Stomatotech Inc.
EU Authorized Representative
MDSS GmbH
Schiffgraben 4130175 Hannover
Germany
MDSS GmbH acts as the EU Authorized Representative for Stomatotech Inc. under Article 11 of EU MDR 2017/745 for the Crown Down Surgical Drilling Kit placed on the EU market.
Regulatory status
The Crown Down Surgical Drilling Kit is classified as a Class I medical device under Regulation (EU) 2017/745 (EU Medical Device Regulation). The device is supplied non-sterile, is reusable, and is intended for professional use only by trained dental professionals.
The Instructions for Use are provided electronically in accordance with Commission Implementing Regulation (EU) 2021/2226 and are also available as a downloadable fixed-format PDF.
Reporting a device complaint or incident
If you are a clinician, dental facility, or patient with a complaint, suspected device defect, performance problem, packaging issue, labeling issue, or adverse event to report, contact us at info@crowndownkit.com. Include the device name, lot/batch number if available, catalogue reference, a description of the event, the clinical context, and photographs where possible.
Serious incidents involving the device should also be reported to the competent authority of the EU Member State in which the user and/or patient is established, in accordance with EU MDR 2017/745 Article 87.
Corporate identity & traceability
- Brand
- Crown Down
- Legal manufacturer
- Stomatotech Inc.
- Manufacturer country
- Canada
- EU Authorized Representative
- MDSS GmbH (Hannover, DE)
- Device
- Crown Down Surgical Drilling Kit
- Classification
- Class I under Regulation (EU) 2017/745
- Regulatory status
- Non-sterile, reusable, professional use only
- IFU reference
- IFU-CDK-001 Rev. 01