The following data is part of a premarket notification filed by Oral-b Laboratories with the FDA for Oral-b Perioflex Subgingival Irrigator.
| Device ID | K943182 |
| 510k Number | K943182 |
| Device Name: | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR |
| Classification | Unit, Oral Irrigation |
| Applicant | ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
| Contact | Sharon Snyder |
| Correspondent | Sharon Snyder ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-01 |
| Decision Date | 1994-09-09 |