The following data is part of a premarket notification filed by Deldent Ltd. with the FDA for Deldent Ultrasonic Inserts.
| Device ID | K011179 |
| 510k Number | K011179 |
| Device Name: | DELDENT ULTRASONIC INSERTS |
| Classification | Scaler, Ultrasonic |
| Applicant | DELDENT LTD. 19 KEREN KAYEMET ST. Petach Tikvah, IL 49372 |
| Contact | Alan Edel |
| Correspondent | Alan Edel DELDENT LTD. 19 KEREN KAYEMET ST. Petach Tikvah, IL 49372 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-17 |
| Decision Date | 2001-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016281569 | K011179 | 000 |
| 10843471113926 | K011179 | 000 |
| 10843471113902 | K011179 | 000 |
| 10843471113896 | K011179 | 000 |
| 10843471113889 | K011179 | 000 |
| 10843471113438 | K011179 | 000 |
| 10843471113414 | K011179 | 000 |
| 10840326418588 | K011179 | 000 |
| 10840326418571 | K011179 | 000 |
| 10840326418564 | K011179 | 000 |
| 10840326418557 | K011179 | 000 |
| 10840326418540 | K011179 | 000 |
| 10840326418533 | K011179 | 000 |
| 10840326418526 | K011179 | 000 |
| 10840326418519 | K011179 | 000 |
| 10816577022737 | K011179 | 000 |
| 10816577022676 | K011179 | 000 |
| 10816577022393 | K011179 | 000 |
| 07290016281101 | K011179 | 000 |
| 07290016281118 | K011179 | 000 |
| 07290016281552 | K011179 | 000 |
| 07290016281545 | K011179 | 000 |
| 07290016281514 | K011179 | 000 |
| 07290016281460 | K011179 | 000 |
| 07290016281453 | K011179 | 000 |
| 07290016281446 | K011179 | 000 |
| 07290016281415 | K011179 | 000 |
| 07290016281279 | K011179 | 000 |
| 07290016281262 | K011179 | 000 |
| 07290016281255 | K011179 | 000 |
| 07290016281248 | K011179 | 000 |
| 07290016281217 | K011179 | 000 |
| 07290016281200 | K011179 | 000 |
| 07290016281170 | K011179 | 000 |
| 07290016281163 | K011179 | 000 |
| 07290016281156 | K011179 | 000 |
| 07290016281149 | K011179 | 000 |
| 10816577021594 | K011179 | 000 |