The following data is part of a premarket notification filed by Ardent Intl., Inc. with the FDA for Siliva Ejector/oral Cavity Evacuator.
| Device ID | K864300 |
| 510k Number | K864300 |
| Device Name: | SILIVA EJECTOR/ORAL CAVITY EVACUATOR |
| Classification | Mouthpiece, Saliva Ejector |
| Applicant | ARDENT INTL., INC. 165 MANSION RD. Newtown Square, PA 19073 |
| Contact | B. N Stahlman |
| Correspondent | B. N Stahlman ARDENT INTL., INC. 165 MANSION RD. Newtown Square, PA 19073 |
| Product Code | DYN |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-31 |
| Decision Date | 1986-11-24 |