510(k) K801780
K801780 is an FDA 510(k) premarket notification submitted by Oxy Dental Products, Inc. for the device "OXY CUSTOM TRAY RESIN". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. Oxy Dental Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1980
- Date Received
- July 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression Tray, Resin
- Device Class
- Class I
- Regulation Number
- 872.3670
- Review Panel
- DE
- Submission Type