The following data is part of a premarket notification filed by Whitehill Oral Technologies, Inc. with the FDA for Perio-med Dental Floss.
| Device ID | K944034 |
| 510k Number | K944034 |
| Device Name: | PERIO-MED DENTAL FLOSS |
| Classification | Floss, Dental |
| Applicant | WHITEHILL ORAL TECHNOLOGIES, INC. 950 HIGHWAY 36 Hazlet, NJ 07730 |
| Contact | Ira Hill |
| Correspondent | Ira Hill WHITEHILL ORAL TECHNOLOGIES, INC. 950 HIGHWAY 36 Hazlet, NJ 07730 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1995-07-25 |