510(k) K833338
K833338 is an FDA 510(k) premarket notification submitted by Joel Lander D.D.S. for the device "TOOTH SLOOTH". The FDA issued a decision of Substantially Equivalent on November 25, 1983. The device falls under product code EJB (Handle, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1983
- Date Received
- September 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handle, Instrument, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type