MUCOPREN SOFT RELINING SYSTEM— 510(k) K983357
Substantially EquivalentRoydent Dental Products, Inc.
FDA 510(k) clearance K983357 for MUCOPREN SOFT RELINING SYSTEM, Substantially Equivalent on 1998-11-13. Applicant: Roydent Dental Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Roydent Dental Products, Inc.
- Product code
- Code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester Hills, MI, US
Recent devices under product code EBI
view allMore clearances from Roydent Dental Products, Inc.
view allAdverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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