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510(k) K760796

ORALUMINATOR III - LIGHT SOURCE FOR F.O. by Midwest — Product Code EAY

K760796 is an FDA 510(k) premarket notification submitted by Midwest for the device "ORALUMINATOR III - LIGHT SOURCE FOR F.O.". The FDA issued a decision of Substantially Equivalent on October 20, 1976. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Midwest has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1976
Date Received
October 8, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Fiber Optic, Dental
Device Class
Class I
Regulation Number
872.4620
Review Panel
DE
Submission Type

Other clearances by Midwest

  • K863677 — TRADITION HIGH SPEED HANDPIECE (October 6, 1986)
  • K850344 — AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG (March 25, 1985)
  • K792445 — MW STRAIGHT ATTACHMENT (December 6, 1979)
  • K792302 — LS-100 (November 27, 1979)
  • K792303 — MW 8000-I (November 27, 1979)
  • K792304 — MW-8000 (November 27, 1979)
  • K791771 — ORALUMINATOR III AUTO-LIGHT (November 20, 1979)
  • K791733 — LIGHT-PAK (October 23, 1979)
  • K790113 — MIDWEST 1000 (February 26, 1979)
  • K781878 — LIGHT, INSIDE (December 29, 1978)

Other clearances for product code EAY

  • K953191 — MODEL A15-101 (September 5, 1995)
  • K953192 — MODEL A15-103 (September 5, 1995)
  • K935718 — JEDENTAL VLC DENTAL CURING LIGHT (January 26, 1994)
  • K871816 — STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM (August 3, 1987)
  • K831976 — POWER OPTIC (August 12, 1983)
  • K831824 — DENTAL ELECTRONIC/S.B.R TRADING BU HAND (August 11, 1983)
  • K820907 — DENTISCOPE (May 5, 1982)
  • K812605 — FIBER OPTIC LIGHT SOURCE I (October 2, 1981)
  • K802684 — HELIOMAT (November 24, 1980)
  • K802716 — DEN-MAT FIBER OPTIC HALOGEN LIGHT (November 12, 1980)

FDA data resources