ISODENT— 510(k) K894058
Substantially EquivalentEurodent, Inc.
FDA 510(k) clearance K894058 for ISODENT, Substantially Equivalent on 1989-12-21. Applicant: Eurodent, Inc.. Device class: 1.
Clearance details
- Applicant
- Eurodent, Inc.
- Product code
- Code EIA
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Canada J4b 5z5, CA
Recent devices under product code EIA
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