The following data is part of a premarket notification filed by Advanced Bio Systems, Inc. with the FDA for Dental Oral Care Systems & Components.
| Device ID | K844480 |
| 510k Number | K844480 |
| Device Name: | DENTAL ORAL CARE SYSTEMS & COMPONENTS |
| Classification | Denture Repair Kit |
| Applicant | ADVANCED BIO SYSTEMS, INC. 80 E. HAWTHORNE AVE. Valley Stream, NY 11580 |
| Contact | Tracey Prat |
| Correspondent | Tracey Prat ADVANCED BIO SYSTEMS, INC. 80 E. HAWTHORNE AVE. Valley Stream, NY 11580 |
| Product Code | EBO |
| CFR Regulation Number | 872.3570 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-19 |
| Decision Date | 1985-06-19 |