FDA 510(k) Applications for Medical Device:
Laser, Dental, Soft Tissue
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K210350 | Azena Medical, LLC |
3021 Citrus Circle Suite 180 | Walnut Creek | CA | 94598 |
| K213428 | Biolase Inc. |
27042 Towne Centre Drive, Suite 270 | Foothill Ranch | CA | 92610 |
| K221761 | Convergent Dental, Inc. |
140 Kendrick Street | Needham | MA | 02494 |
| K201387 | DentLight Inc. |
1825 Summit Ave. Ste 210 | Plano | TX | 75074 |
| K213658 | El.En Electronic Engineering Spa |
Via Baldanzese 17 | Calenzano | FL | 50041 |
| K203396 | El.En. Electronic Engineering Spa |
Via Baldanzese 17 | Calenzano | 50041 | |
| K210367 | Guilin Woodpecker Medical Instrument Co., Ltd. |
Information Industrial Park, Guilin National High-Tech Zone | Guilin | 541004 | |
| K030146 | KAVO AMERICA |
340 EAST MAIN ST. | LAKE ZURICH | IL | 60047 |
| K214008 | Shenzhen Soga Technology Co., Ltd. |
D906, Yinxing Technology Building No. 1301, Sightseeing Road | Shenzhen | 518110 | |
| K211150 | Shenzhen Soga Technology Co., Ltd. |
D906, Yinxing Technology Building No. 1301, Sightseeing | Shenzhen | 518110 |
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