510(k) K070287
- Device
- PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
- Applicant
- PHOTONIC OPTISCHE GERATE GMBH & COKG
- 510(k) number
- K070287
- Product code
- EBA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-12
- Date received
- 2007-01-29
- Regulation
- 872.4630
- Classification name
- Light, Surgical Headlight
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- DIETER FEGER
- Address
- Seebockgasse 59 Vienna AT A-1160 A-1160
FDA Registration Numbers#
- 3002858762
- 3023194894
- 8010482
- 3013247477
- 1651260
- 1836161
- 1645452
- 3030519472
- 1035968
- 3016875543
- 3009171220
- 3003431869
- 3015532203
- 3007165189
- 3010726901
- 3005775121
- 9611503
- 3043303267
- 3005515469
- 3006799849
- 2433629
- 3014268446
- 3021368823
- 3016891393
- 3003848022
- 3003882387
- 3008860098
- 3010373530
- 3010202439
- 2936485
- 9680718
- 2020550
- 1000391004
- 3006252153
- 8010298
- 3011137372
- 3014023477
- 3006142527
- 3013846070
- 3010041511
- 2921577
Source Documents#
Other 510(k) Records For Product Code EBA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM | Sylvan Medical Fiberoptics | 1992-10-16 |
| K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | 1989-06-22 |
| K854646 | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. | 1986-03-06 |
| K842515 | SURGICAL HEADLIGHT | Good-Lite Co. | 1984-08-02 |
| K842358 | ISOLIGHT | Planmeca USA, Inc. | 1984-07-31 |
| K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. | 1982-09-28 |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | 1981-02-10 |
| K790806 | PORCELIT | Harry J. Bosworth Co. | 1979-08-03 |
| K790807 | METALIT | Harry J. Bosworth Co. | 1979-08-03 |
Legacy Summary#
summary
FDA Review#
Decision Summary