Ora Innovations, Inc. · Class I · Cleared Nov 18, 1998
| K-number | K983168 |
| Device name | AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 |
| Applicant | Ora Innovations, Inc. |
| Product code | EFB |
| Device class | Class I |
| Decision date | Nov 18, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 872.4200 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov