510(k) K912820
K912820 is an FDA 510(k) premarket notification submitted by E&D Dental Products, Inc. for the device "POLYESTER RESIN HAND MOLDED TRAY". The FDA issued a decision of Substantially Equivalent on August 21, 1991. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. E&D Dental Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1991
- Date Received
- June 25, 1991
- 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