The following data is part of a premarket notification filed by Rolence Enteprise, Inc. with the FDA for Zoomcam Ld-10 Intraoral Camera And Accessories.
| Device ID | K043325 |
| 510k Number | K043325 |
| Device Name: | ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES |
| Classification | Unit, Operative Dental |
| 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 | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-02-11 |