510(k) K181604
K181604 is an FDA 510(k) premarket notification submitted by Hrs Co., Ltd. for the device "Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite". The FDA issued a decision of Substantially Equivalent on Nov 28, 2018. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Hrs Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 28, 2018
- Date Received
- Jun 19, 2018
- 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
- 510(k)