The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aeu-6000 Implant / Endodontic Dental System.
| Device ID | K142124 |
| 510k Number | K142124 |
| Device Name: | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | ASEPTICO, INC. 8333 216th St SE Woodinville, WA 98072 |
| Contact | Cherie Tregoning |
| Correspondent | Cherie Tregoning ASEPTICO, INC. 8333 216th St SE 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 | 2014-08-04 |
| Decision Date | 2014-12-31 |