510(k) K173608
K173608 is an FDA 510(k) premarket notification submitted by Forest Dental Products, Inc. for the device "Forest Dental Unit". The FDA issued a decision of Substantially Equivalent on Aug 17, 2018. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 17, 2018
- Date Received
- Nov 21, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
- 510(k)