The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aeu-7000l-70v Implant/endodontic Dental System (lighted Version).
| Device ID | K150129 |
| 510k Number | K150129 |
| Device Name: | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Aseptico, Inc. 8333 216th St. S.E. Woodinville, WA 98072 |
| Contact | Cherie Tregoning |
| Correspondent | Cherie Tregoning Aseptico, Inc. 8333 216th St. S.E. Woodinville, WA 98072 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-21 |
| Decision Date | 2015-05-28 |