510(k) K905582
K905582 is an FDA 510(k) premarket notification submitted by Milton Hodosh, M.D. for the device "POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND". The FDA issued a decision of Substantially Equivalent on April 29, 1991. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Milton Hodosh, M.D. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1991
- Date Received
- December 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Pit And Fissure, And Conditioner
- Device Class
- Class II
- Regulation Number
- 872.3765
- Review Panel
- DE
- Submission Type