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510(k) K854646

VEGA DENTAL OPERATING LIGHT by Alpine Dental Equipment Co. — Product Code EBA

K854646 is an FDA 510(k) premarket notification submitted by Alpine Dental Equipment Co. for the device "VEGA DENTAL OPERATING LIGHT". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code EBA (Light, Surgical Headlight), a Class I device regulated under 21 CFR 872.4630. Alpine Dental Equipment Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1986
Date Received
November 19, 1985
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 Alpine Dental Equipment Co.

  • K880474 — AREA (DENTAL CHAIR) (September 23, 1988)
  • K880475 — SKEMA (DENTAL UNIT) (September 23, 1988)
  • K854647 — POLO DENTAL UNIT (June 5, 1986)
  • K854643 — SOLAR (March 14, 1986)
  • K854642 — SOLAR CART (March 14, 1986)
  • K854645 — GOLD AIR, GOLD LIGHT (March 12, 1986)
  • K854641 — SOLAR F (March 10, 1986)
  • K854741 — X-RANGE 65 (March 6, 1986)
  • K854644 — MANTA DENTAL CHAIR (January 23, 1986)

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)
  • 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)
  • K790806 — PORCELIT (August 3, 1979)
  • K790807 — METALIT (August 3, 1979)

FDA data resources