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510(k) K831824

DENTAL ELECTRONIC/S.B.R TRADING BU HAND by Silverman'S — Product Code EAY

K831824 is an FDA 510(k) premarket notification submitted by Silverman'S for the device "DENTAL ELECTRONIC/S.B.R TRADING BU HAND". The FDA issued a decision of Substantially Equivalent on August 11, 1983. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Silverman'S has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1983
Date Received
June 7, 1983
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 Silverman'S

  • K801975 — LITTLE GIANT I & II HANDPIECE CONTROL (September 9, 1980)

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)
  • 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)
  • K801591 — FIBER OPTIC ILLUMINATOR (July 21, 1980)

FDA data resources