The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Dental Needle.
| Device ID | K861150 |
| 510k Number | K861150 |
| Device Name: | EXEL DENTAL NEEDLE |
| Classification | Needle, Dental |
| Applicant | EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Contact | Eshagh Hamid |
| Correspondent | Eshagh Hamid EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Product Code | DZM |
| CFR Regulation Number | 872.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-26 |
| Decision Date | 1986-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020221900702 | K861150 | 000 |
| 30020221265607 | K861150 | 000 |
| 10020221900801 | K861150 | 000 |
| 10020221900900 | K861150 | 000 |
| 30020221265553 | K861150 | 000 |
| 30020221265577 | K861150 | 000 |
| 30020221265584 | K861150 | 000 |
| 30020221265621 | K861150 | 000 |
| 10020221900108 | K861150 | 000 |
| 10020221900504 | K861150 | 000 |
| 10020221900603 | K861150 | 000 |
| 30020221265591 | K861150 | 000 |