The following data is part of a premarket notification filed by Heka Dental A/s with the FDA for Unicline Mobile.
| Device ID | K150490 |
| 510k Number | K150490 |
| Device Name: | UnicLine Mobile |
| Classification | Unit, Operative Dental |
| Applicant | Heka Dental A/S Balsershoj 38 Dk-2635 Ishoj, DK |
| Contact | Claus Van Der Goot |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-02-25 |
| Decision Date | 2015-04-17 |
| Summary: | summary |