510(k) K854527
K854527 is an FDA 510(k) premarket notification submitted by The Hygenic Corp. for the device "STICKY WAX". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code EGD (Wax, Dental, Intraoral), a Class I device regulated under 21 CFR 872.6890. The Hygenic Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1986
- Date Received
- November 13, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Dental, Intraoral
- Device Class
- Class I
- Regulation Number
- 872.6890
- Review Panel
- DE
- Submission Type