510(k) K203309
K203309 is an FDA 510(k) premarket notification submitted by JJGC Indústria e Comércio de Materiais Dentários S.A. for the device "NUVO CF Implant System". The FDA issued a decision of Substantially Equivalent on July 6, 2021. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. JJGC Indústria e Comércio de Materiais Dentários S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2021
- Date Received
- November 10, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type