Tün® Ultrasonic Tips Product Family
Scaler, Ultrasonic
Engineered Endodontics
The following data is part of a premarket notification filed by Engineered Endodontics with the FDA for Tün® Ultrasonic Tips Product Family.
Pre-market Notification Details
| Device ID | K182145 |
| 510k Number | K182145 |
| Device Name: | Tün® Ultrasonic Tips Product Family |
| Classification | Scaler, Ultrasonic |
| Applicant | Engineered Endodontics W134 N4965 Campbell Drive Menomonee Falls, WI 53051 |
| Contact | Mark Fiorina |
| Correspondent | John Ziobro SpectraMedEx, LLC 3215 Golf Road #1459 Delafield, WI 53018 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-08 |
| Decision Date | 2019-06-07 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889813028254 | K182145 | 000 |
| 00889813028155 | K182145 | 000 |
| 00889813028162 | K182145 | 000 |
| 00889813028179 | K182145 | 000 |
| 00889813028186 | K182145 | 000 |
| 00889813028193 | K182145 | 000 |
| 00889813028209 | K182145 | 000 |
| 00889813028216 | K182145 | 000 |
| 00889813028223 | K182145 | 000 |
| 00889813028230 | K182145 | 000 |
| 00889813028247 | K182145 | 000 |
| 00889813028148 | K182145 | 000 |
Trademark Results [Tün]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TUN 88117937 not registered Live/Pending |
Robern, Inc. 2018-09-14 |
 TUN 88024772 not registered Dead/Abandoned |
Michael Kudirka 2018-07-03 |
 TUN 78502150 3035196 Dead/Cancelled |
The University Network, LLC 2004-10-19 |
 TUN 77465622 not registered Dead/Abandoned |
Swift Records, Inc. 2008-05-05 |
 TUN 75136797 2523750 Live/Registered |
SA Esker 1996-07-19 |
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