The following data is part of a premarket notification filed by Beyond 21st Century, Inc. with the FDA for Breath Ace Breathfreshener.
| Device ID | K972131 |
| 510k Number | K972131 |
| Device Name: | BREATH ACE BREATHFRESHENER |
| Classification | Scraper, Tongue |
| Applicant | BEYOND 21ST CENTURY, INC. 13706 WEST 75TH PL. Lenexa, KS 66216 -4229 |
| Contact | Hemant K Thakur |
| Correspondent | Hemant K Thakur BEYOND 21ST CENTURY, INC. 13706 WEST 75TH PL. Lenexa, KS 66216 -4229 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-06 |
| Decision Date | 1997-07-18 |