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 FDA 510(k) cleared as a Class II dental device under 21 CFR 872.4130. CE marking is pending.
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.
US regulatory clearance
FDA 510(k) cleared
Class II dental device under 21 CFR 872.4130. Cleared for professional use by trained dental clinicians for dental implant osteotomy preparation.
510(k) clearance number and supporting regulatory documentation are available on request through info@crowndownkit.com.
Regulatory status
The Crown Down Surgical Drilling Kit is FDA 510(k) cleared as a Class II dental device under 21 CFR 872.4130. 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 on this website and are also available as a downloadable fixed-format PDF. CE conformity assessment is pending; the device is not currently sold in markets requiring CE marking.
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 adverse events involving the device may also be reported directly to the US FDA via the MedWatch program, or through the medical device regulatory authority in the user's jurisdiction.
Corporate identity & traceability
- Brand
- Crown Down
- Legal manufacturer
- Stomatotech Inc.
- Manufacturer country
- Canada
- US regulatory clearance
- FDA 510(k) cleared
- Device
- Crown Down Surgical Drilling Kit
- Classification
- Class II dental device under 21 CFR 872.4130
- Regulatory status
- Non-sterile, reusable, professional use only
- IFU reference
- IFU-CDK-001 Rev. 01