The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Endo-eze Motor And Handpiece.
| Device ID | K992380 |
| 510k Number | K992380 |
| Device Name: | ENDO-EZE MOTOR AND HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Scott E Moore |
| Correspondent | Scott E Moore ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-16 |
| Decision Date | 1999-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107817 | K992380 | 000 |
| 00883205021076 | K992380 | 000 |