510(k) K802189
K802189 is an FDA 510(k) premarket notification submitted by U.S. Shizai Corp. for the device "DENTLOID". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. U.S. Shizai Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1980
- Date Received
- September 10, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type