510(k) K973370
K973370 is an FDA 510(k) premarket notification submitted by Wfr/Aquaplast Corp. for the device "AQUAPLAST PALATAL STENT". The FDA issued a decision of Substantially Equivalent on December 2, 1997. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Wfr/Aquaplast Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1997
- Date Received
- September 8, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type