TEETHMATE F-1— 510(k) K012742
Substantially EquivalentKuraray Medical, Inc.
FDA 510(k) clearance K012742 for TEETHMATE F-1, Substantially Equivalent on 2001-09-14. Applicant: Kuraray Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Kuraray Medical, Inc.
- Product code
- Code EBC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3765
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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