FDA Product Code
FDA Product Code EBA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4630
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K070287 | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | 2007-02-12 | Traditional | PDF ↗ |
| K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM | Sylvan Medical Fiberoptics | 1992-10-16 | Traditional | PDF ↗ |
| K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | 1989-06-22 | Traditional | PDF ↗ |
| K854646 | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. | 1986-03-06 | Traditional | PDF ↗ |
| K842515 | SURGICAL HEADLIGHT | Good-Lite Co. | 1984-08-02 | Traditional | PDF ↗ |
| K842358 | ISOLIGHT | Planmeca USA, Inc. | 1984-07-31 | Traditional | PDF ↗ |
| K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | 1981-02-10 | Traditional | PDF ↗ |
| K790807 | METALIT | Harry J. Bosworth Co. | 1979-08-03 | Traditional | PDF ↗ |
| K790806 | PORCELIT | Harry J. Bosworth Co. | 1979-08-03 | Traditional | PDF ↗ |
Product code EBA · Class I · Dental. Data: openFDA.