510(k) K863021
K863021 is an FDA 510(k) premarket notification submitted by Sds Dental, Inc. for the device "CM-II, CM-I WATER UNIT". The FDA issued a decision of Substantially Equivalent on October 1, 1986. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Sds Dental, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1986
- Date Received
- August 8, 1986
- 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