The following data is part of a premarket notification filed by Oral Health Technologies, Llc with the FDA for Cleanse.freshen.go; Aligner Cleansing Towelette And Dental Appliance Cleanser.
| Device ID | K080631 |
| 510k Number | K080631 |
| Device Name: | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | ORAL HEALTH TECHNOLOGIES, LLC 1062 ALLEGHENY DRIVE Danville, CA 94526 |
| Contact | Robert E Tricca |
| Correspondent | Robert E Tricca ORAL HEALTH TECHNOLOGIES, LLC 1062 ALLEGHENY DRIVE Danville, CA 94526 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-05 |
| Decision Date | 2008-05-23 |
| Summary: | summary |