The following data is part of a premarket notification filed by Tom's Of Maine, Inc. with the FDA for Tom's Naturally Waxed Flossing Tape.
| Device ID | K821685 |
| 510k Number | K821685 |
| Device Name: | TOM'S NATURALLY WAXED FLOSSING TAPE |
| Classification | Floss, Dental |
| Applicant | TOM'S OF MAINE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-08-12 |