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510(k) K842358

ISOLIGHT by Planmeca USA, Inc. — Product Code EBA

K842358 is an FDA 510(k) premarket notification submitted by Planmeca USA, Inc. for the device "ISOLIGHT". The FDA issued a decision of Substantially Equivalent on July 31, 1984. The device falls under product code EBA (Light, Surgical Headlight), a Class I device regulated under 21 CFR 872.4630. Planmeca USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1984
Date Received
June 22, 1984
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 Planmeca USA, Inc.

  • K111361 — PLANMED NUANCE EXCEL (September 23, 2011)
  • K081699 — PLANMECA SOVEREIGN (August 29, 2008)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K923533 — ADMARK (March 4, 1993)
  • K923461 — PM2002 PROLINE, PM2002 PROLINE EC (December 21, 1992)
  • K923462 — DELIGHT (December 21, 1992)
  • K904953 — PLANMED SOPHIE (April 18, 1991)
  • K904948 — PM2002 CC AND PM2002 EC (January 30, 1991)
  • K904947 — PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE (January 30, 1991)
  • K864474 — DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC (November 26, 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)
  • K854646 — VEGA DENTAL OPERATING LIGHT (March 6, 1986)
  • K842515 — SURGICAL HEADLIGHT (August 2, 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