The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Aeu-26l Elctronic Endodontic System.
| Device ID | K111078 |
| 510k Number | K111078 |
| Device Name: | AEU-26L ELCTRONIC ENDODONTIC SYSTEM |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Grant Ramaley |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110023452 | K111078 | 000 |
| 00813110023414 | K111078 | 000 |