510(k) K852743
K852743 is an FDA 510(k) premarket notification submitted by The S. S. White Co. for the device "PORCELAIN VENEER SYSTEM LABORATORY KIT". The FDA issued a decision of Substantially Equivalent on July 31, 1985. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. The S. S. White Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1985
- Date Received
- June 27, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type