510(k) K800900
K800900 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "PREMIER TRIPLE TRAY". The FDA issued a decision of Substantially Equivalent on April 29, 1980. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1980
- Date Received
- April 18, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Impression, Preformed
- Device Class
- Class I
- Regulation Number
- 872.6880
- Review Panel
- DE
- Submission Type