DENPAX— 510(k) K860058
Substantially EquivalentNissho Iwai American Corp.
FDA 510(k) clearance K860058 for DENPAX, Substantially Equivalent on 1986-03-12. Applicant: Nissho Iwai American Corp.. Device class: 1.
Clearance details
- Applicant
- Nissho Iwai American Corp.
- Product code
- Code EBR
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code EBR
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