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510(k) K923949

SYLVAN DENTAL HEADLIGHT SYSTEM by Sylvan Medical Fiberoptics — Product Code EBA

K923949 is an FDA 510(k) premarket notification submitted by Sylvan Medical Fiberoptics for the device "SYLVAN DENTAL HEADLIGHT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 1992. The device falls under product code EBA (Light, Surgical Headlight), a Class I device regulated under 21 CFR 872.4630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1992
Date Received
August 5, 1992
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 for product code EBA

  • K070287 — PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (February 12, 2007)
  • 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)
  • K790806 — PORCELIT (August 3, 1979)

FDA data resources