The following data is part of a premarket notification filed by Rolence Enteprise, Inc. with the FDA for Ultrasonic Scaler Elegance Ms-10 (25k).
| Device ID | K040396 |
| 510k Number | K040396 |
| Device Name: | ULTRASONIC SCALER ELEGANCE MS-10 (25K) |
| Classification | Scaler, Ultrasonic |
| Applicant | ROLENCE ENTEPRISE, INC. 18-3, LANE 231 PU-CHUNG ROAD Chungi, TW 320 |
| Contact | Sterling Cheng |
| Correspondent | Sterling Cheng ROLENCE ENTEPRISE, INC. 18-3, LANE 231 PU-CHUNG ROAD Chungi, TW 320 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040028629 | K040396 | 000 |
| 00810113691046 | K040396 | 000 |
| 00810113691053 | K040396 | 000 |
| 00810113691060 | K040396 | 000 |
| D884FMS25300 | K040396 | 000 |
| 04713909450512 | K040396 | 000 |
| 04713909450529 | K040396 | 000 |
| 04713909450536 | K040396 | 000 |
| 04713909450543 | K040396 | 000 |
| 04713909450550 | K040396 | 000 |
| 04713909450567 | K040396 | 000 |
| 04713909450574 | K040396 | 000 |
| 04713909450581 | K040396 | 000 |
| 04713909450598 | K040396 | 000 |
| 04713909450604 | K040396 | 000 |
| 00810113691039 | K040396 | 000 |