Porcelit
FDA 510(k) K790806 · Harry J. Bosworth Co.
510(k) numberK790806
Submission
- Device name
- Porcelit
- Applicant
- Harry J. Bosworth Co.
Mchenry, IL, US - Received
- April 24, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070287 | PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500EBA · Traditional | Photonic Optische Gerate GmbH & Cokg | 02/12/2007SE |
| K923949 | Sylvan Dental Headlight SystemEBA · Traditional | Sylvan Medical Fiberoptics | 10/16/1992SE |
| K893458 | Fiberoptic Headlight SystemEBA · Traditional | Cuda Products Co. | 06/22/1989SE |
| K854646 | Vega Dental Operating LightEBA · Traditional | Alpine Dental Equipment Co. | 03/06/1986SE |
| K842515 | Surgical HeadlightEBA · Traditional | Good-Lite Co. | 08/02/1984SE |
| K842358 | IsolightEBA · Traditional | Planmeca USA, Inc. | 07/31/1984SE |
| K822265 | Fiberoptic Light Source W/Related ItemsEBA · Traditional | Kelleher Corp. | 09/28/1982SE |
| K810117 | Halogen Headlight SystemEBA · Traditional | Colmed, Ltd. | 02/10/1981SE |
| K790807 | MetalitEBA · Traditional | Harry J. Bosworth Co. | 08/03/1979SE |
More from Harry J. Bosworth Co.
| 510(k) | Device | Decision |
|---|---|---|
| K103585 | Bosworth Aegis Liner & Restorative Material W/AcpEMA · Traditional | 03/04/2011SE |
| K100731 | Bosworth Air PolisherEFB · Traditional | 12/03/2010SE |
| K061611 | Bosworth Dentin ResinKLE · Traditional | 09/11/2006SE |
| K051224 | Bosworth SealEBC · Traditional | 07/28/2005SE |
| K043170 | Bosworth BondKLE · Traditional | 02/25/2005SE |
| K040548 | Aegis Ortho Light-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K040547 | Aegis Ortho Dual-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K033751 | Aegis Pit & Fissure Sealant with AcpEBC · Traditional | 02/05/2004SE |
| K031439 | Alginate Impression Material III (Fast & Regular)ELW · Traditional | 10/02/2003SE |
| K031811 | Pit & Fissure Sealant with FluorideEBC · Traditional | 09/04/2003SE |
Questions and answers
When was Porcelit cleared by the FDA?
Porcelit (K790806) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 101 days after the submission was received.
What is the product code of K790806?
The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.