Solea— 510(k) K221761
Substantially EquivalentConvergent Dental, Inc.
FDA 510(k) clearance K221761 for Solea, Substantially Equivalent on 2022-09-14. Applicant: Convergent Dental, Inc.. Device class: 2.
Clearance details
- Applicant
- Convergent Dental, Inc.
- Product code
- Code NVK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Needham, MA, US
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More clearances from Convergent Dental, Inc.
view allRecalls naming K221761
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221761.
Data sourced from openFDA. This site is unofficial and independent of the FDA.