The following data is part of a premarket notification filed by Aseptic Dental Technologies, Inc. with the FDA for Aseptic Dental Tech. Total Treatment System.
| Device ID | K914562 |
| 510k Number | K914562 |
| Device Name: | ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM |
| Classification | Needle, Dental |
| Applicant | ASEPTIC DENTAL TECHNOLOGIES, INC. 615 MAYFAIR Arlington Heights, IL 60005 |
| Contact | David Ruggio |
| Correspondent | David Ruggio ASEPTIC DENTAL TECHNOLOGIES, INC. 615 MAYFAIR Arlington Heights, IL 60005 |
| Product Code | DZM |
| CFR Regulation Number | 872.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-15 |
| Decision Date | 1992-03-09 |