510(k) K914513
K914513 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "PALAVIT G". The FDA issued a decision of Substantially Equivalent on March 19, 1992. The device falls under product code EGD (Wax, Dental, Intraoral), a Class I device regulated under 21 CFR 872.6890. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1992
- Date Received
- October 9, 1991
- 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