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510(k) K790806

PORCELIT by Harry J. Bosworth Co. — Product Code EBA

K790806 is an FDA 510(k) premarket notification submitted by Harry J. Bosworth Co. for the device "PORCELIT". The FDA issued a decision of Substantially Equivalent on August 3, 1979. The device falls under product code EBA (Light, Surgical Headlight), a Class I device regulated under 21 CFR 872.4630. Harry J. Bosworth Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
April 24, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical Headlight
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances by Harry J. Bosworth Co.

  • K103585 — BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP (March 4, 2011)
  • K100731 — BOSWORTH AIR POLISHER (December 3, 2010)
  • K061611 — BOSWORTH DENTIN RESIN (September 11, 2006)
  • K051224 — BOSWORTH SEAL (July 28, 2005)
  • K043170 — BOSWORTH BOND (February 25, 2005)
  • K040547 — AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE (March 19, 2004)
  • K040548 — AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE (March 19, 2004)
  • K033751 — AEGIS PIT & FISSURE SEALANT WITH ACP (February 5, 2004)
  • K031439 — ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) (October 2, 2003)
  • K031811 — PIT & FISSURE SEALANT WITH FLUORIDE (September 4, 2003)

Other clearances for product code EBA

  • K070287 — PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (February 12, 2007)
  • K923949 — SYLVAN DENTAL HEADLIGHT SYSTEM (October 16, 1992)
  • K893458 — FIBEROPTIC HEADLIGHT SYSTEM (June 22, 1989)
  • K854646 — VEGA DENTAL OPERATING LIGHT (March 6, 1986)
  • K842515 — SURGICAL HEADLIGHT (August 2, 1984)
  • K842358 — ISOLIGHT (July 31, 1984)
  • K822265 — FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS (September 28, 1982)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K790807 — METALIT (August 3, 1979)

FDA data resources