The following data is part of a premarket notification filed by Pacific Rim Dental, Inc. with the FDA for Re Nu.
| Device ID | K973289 |
| 510k Number | K973289 |
| Device Name: | RE NU |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | PACIFIC RIM DENTAL, INC. 173CD SHADY LN. P.O. BOX 2147 Stateline, NV 89449 |
| Contact | Kathy L Eppen |
| Correspondent | Kathy L Eppen PACIFIC RIM DENTAL, INC. 173CD SHADY LN. P.O. BOX 2147 Stateline, NV 89449 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1999-02-09 |