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510(k) K820907

DENTISCOPE by Chayes Virginia, Inc. — Product Code EAY

K820907 is an FDA 510(k) premarket notification submitted by Chayes Virginia, Inc. for the device "DENTISCOPE". The FDA issued a decision of Substantially Equivalent on May 5, 1982. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Chayes Virginia, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1982
Date Received
April 1, 1982
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 Chayes Virginia, Inc.

  • K771873 — VISION SERIES DENTAL CHAIR (October 25, 1977)
  • K771890 — PERCEPTION SERIES DELIVERY SYS. (October 20, 1977)
  • K760599 — DENTAL CHAIRS (September 15, 1976)

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)
  • 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