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510(k) K831976

POWER OPTIC by Ritter Co. — Product Code EAY

K831976 is an FDA 510(k) premarket notification submitted by Ritter Co. for the device "POWER OPTIC". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Ritter Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
June 20, 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 Ritter Co.

  • K831245 — TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO (October 19, 1983)
  • K832171 — SELF CHECK DIGITAL BLOOD PRESS. MONITOR (October 4, 1983)
  • K823180 — SA-21 DENTAL UNIT (November 22, 1982)
  • K800084 — RITTER MODEL J DENTAL CHAIR (January 29, 1980)
  • K781101 — ELECTROSURGICAL UNIT 75 (July 17, 1978)
  • K780293 — ELECTROSURGICAL UNIT (March 14, 1978)
  • K772300 — DENTAL CHAIR, VANGUARD (January 3, 1978)
  • K760929 — ACCUTORQ II (November 19, 1976)
  • K760707 — RITTER STARLIGHT DENTAL OPERATING LIGHT (October 5, 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)
  • 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)
  • K801591 — FIBER OPTIC ILLUMINATOR (July 21, 1980)

FDA data resources