510(k) K211489
K211489 is an FDA 510(k) premarket notification submitted by Nanchang Dental Bright Technology Co., Ltd. for the device "Dental Impression Material". The FDA issued a decision of Substantially Equivalent on July 28, 2021. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2021
- Date Received
- May 13, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type