K894060 is an FDA 510(k) clearance for the ESSE QUATTRO/ESSE UNO. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).
Submitted by Eurodent, Inc. (Canada J4b 5z5, CA). The FDA issued a Cleared decision on September 7, 1989, 92 days after receiving the submission on June 7, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.
| 510(k) Number | K894060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1989 |
| Decision Date | September 07, 1989 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | KLC — Chair, Dental, With Operative Unit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6250 |