510(k) K821788
K821788 is an FDA 510(k) premarket notification submitted by Pacific Dental Corp. for the device "BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT". The FDA issued a decision of Substantially Equivalent on July 6, 1982. The device falls under product code EMJ (Elevator, Surgical, Dental), a Class I device regulated under 21 CFR 872.4565. Pacific Dental Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1982
- Date Received
- June 17, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Surgical, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type