The following data is part of a premarket notification filed by Colgate-palmolive Co. with the FDA for Colgate Dental Floss.
| Device ID | K883335 |
| 510k Number | K883335 |
| Device Name: | COLGATE DENTAL FLOSS |
| Classification | Floss, Dental |
| Applicant | COLGATE-PALMOLIVE CO. 909 RIVER RD. Piscataway, NJ 08855 |
| Contact | Hudson, Phd |
| Correspondent | Hudson, Phd COLGATE-PALMOLIVE CO. 909 RIVER RD. Piscataway, NJ 08855 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-08-26 |