TRICERAM— 510(k) K011428
Substantially EquivalentDentaurum, Inc.
FDA 510(k) clearance K011428 for TRICERAM, Substantially Equivalent on 2001-06-05. Applicant: Dentaurum, Inc.. Device class: 2.
Clearance details
- Applicant
- Dentaurum, Inc.
- Product code
- Code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newtown, PA, US
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