The following data is part of a premarket notification filed by Whitehill Oral Technologies, Inc. with the FDA for Ids Dental Floss With Sodium Fluoride Microdent Dental Floss With Sodium Fluoride Ap-24 Dental Floss With Sodium Fluorid.
| Device ID | K963746 |
| 510k Number | K963746 |
| Device Name: | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID |
| Classification | Floss, Dental |
| Applicant | WHITEHILL ORAL TECHNOLOGIES, INC. 950 HIGHWAY 36 Hazlet, NJ 07730 |
| Contact | Peter P Walters |
| Correspondent | Peter P Walters 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 | 1996-09-17 |
| Decision Date | 1996-12-12 |