The following data is part of a premarket notification filed by Televere Systems, Inc. with the FDA for Televere Digital Dental Imaging System.
| Device ID | K181358 |
| 510k Number | K181358 |
| Device Name: | Televere Digital Dental Imaging System |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Televere Systems, Inc. 1160 Cavalier Road Arnold, MD 21012 |
| Contact | Randell Quaal |
| Correspondent | Robert Bakin Technology And Business Law Advisors, LLC 1244 Capuchino Ave. Burlingame, CA 94010 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-22 |
| Decision Date | 2018-06-20 |
| Summary: | summary |