TEETHMATE-A— 510(k) K897027
Substantially EquivalentKuraray Co.
FDA 510(k) clearance K897027 for TEETHMATE-A, Substantially Equivalent on 1990-03-14. Applicant: Kuraray Co.. Device class: 2.
Clearance details
- Applicant
- Kuraray Co.
- 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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