The following data is part of a premarket notification filed by Good Doctors Co., Ltd. with the FDA for Doctor's Light Led Dental Curing Light.
| Device ID | K071908 |
| 510k Number | K071908 |
| Device Name: | DOCTOR'S LIGHT LED DENTAL CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | GOOD DOCTORS CO., LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Ian P Gordon |
| Correspondent | Ian P Gordon GOOD DOCTORS CO., LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-10 |
| Decision Date | 2007-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800025400071 | K071908 | 000 |