PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
FDA 510(k) clearance K070287 · decided 2007-02-12
Clearance details
- K-number
- K070287
- Device name
- PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
- Applicant
- Photonic Optische Gerate GmbH & Cokg
- Decision
- Substantially Equivalent
- Date received
- 2007-01-29
- Decision date
- 2007-02-12
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- EBA
- Device class
- 1
- Regulation number
- 872.4630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Vienna, AT
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYLVAN DENTAL HEADLIGHT SYSTEM (K923949) | Sylvan Medical Fiberoptics | 1992-10-16 |
| FIBEROPTIC HEADLIGHT SYSTEM (K893458) | Cuda Products Co. | 1989-06-22 |
| VEGA DENTAL OPERATING LIGHT (K854646) | Alpine Dental Equipment Co. | 1986-03-06 |
| SURGICAL HEADLIGHT (K842515) | Good-Lite Co. | 1984-08-02 |
| ISOLIGHT (K842358) | Planmeca USA, Inc. | 1984-07-31 |
| FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS (K822265) | Kelleher Corp. | 1982-09-28 |
| HALOGEN HEADLIGHT SYSTEM (K810117) | Colmed, Ltd. | 1981-02-10 |
| PORCELIT (K790806) | Harry J. Bosworth Co. | 1979-08-03 |
| METALIT (K790807) | Harry J. Bosworth Co. | 1979-08-03 |
Recalls involving this device
No recalls on record reference this clearance.