510(k) K853094
K853094 is an FDA 510(k) premarket notification submitted by Psp Dental Co., Ltd. for the device "EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Psp Dental Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1986
- Date Received
- July 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type