The following data is part of a premarket notification filed by Intl. Dental Design Specialists, Inc. with the FDA for Breath-so-fresh Tongue Cleaner.
| Device ID | K972644 |
| 510k Number | K972644 |
| Device Name: | BREATH-SO-FRESH TONGUE CLEANER |
| Classification | Scraper, Tongue |
| Applicant | INTL. DENTAL DESIGN SPECIALISTS, INC. 629 NINTH ST. Imperial Beach, CA 91932 -1508 |
| Contact | Clifford Yudelman |
| Correspondent | Clifford Yudelman INTL. DENTAL DESIGN SPECIALISTS, INC. 629 NINTH ST. Imperial Beach, CA 91932 -1508 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-15 |
| Decision Date | 1997-09-11 |
| Summary: | summary |