The following data is part of a premarket notification filed by American Eagle Instruments, Inc. with the FDA for Aei Dr. Terauchi Ultrasonic Tips.
| Device ID | K122501 |
| 510k Number | K122501 |
| Device Name: | AEI DR. TERAUCHI ULTRASONIC TIPS |
| Classification | Scaler, Ultrasonic |
| Applicant | AMERICAN EAGLE INSTRUMENTS, INC. 6575 BUTLER CREEK ROAD Missoula, MT 59808 |
| Contact | Kristen Schalliol |
| Correspondent | Kristen Schalliol AMERICAN EAGLE INSTRUMENTS, INC. 6575 BUTLER CREEK ROAD Missoula, MT 59808 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2013-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001745079 | K122501 | 000 |
| 00850001745062 | K122501 | 000 |
| 00850001745055 | K122501 | 000 |
| 00850001745048 | K122501 | 000 |
| 00850001745031 | K122501 | 000 |
| 00850001745024 | K122501 | 000 |