510(k) K972642
K972642 is an FDA 510(k) premarket notification submitted by Estrad B.V. for the device "PERIO CONTROL II". The FDA issued a decision of Substantially Equivalent on January 26, 1998. The device falls under product code EIK (Carver, Wax, Dental), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1998
- Date Received
- July 15, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carver, Wax, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type