The following data is part of a premarket notification filed by Engler Engineering Corp. with the FDA for Engler 25k Series Ultrasonic Inserts.
| Device ID | K122748 |
| 510k Number | K122748 |
| Device Name: | ENGLER 25K SERIES ULTRASONIC INSERTS |
| Classification | Scaler, Ultrasonic |
| Applicant | ENGLER ENGINEERING CORP. 1099 EAST 47TH ST. Hialeah, FL 33013 |
| Contact | Joel Katz |
| Correspondent | Joel Katz ENGLER ENGINEERING CORP. 1099 EAST 47TH ST. Hialeah, FL 33013 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-07 |
| Decision Date | 2013-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00636266958702 | K122748 | 000 |
| 00636266958306 | K122748 | 000 |