510(k) K890712
K890712 is an FDA 510(k) premarket notification submitted by Advantage Dental Products, Inc. for the device "ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS". The FDA issued a decision of Substantially Equivalent on April 25, 1989. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. Advantage Dental Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1989
- Date Received
- February 13, 1989
- 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