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510(k) K802684

HELIOMAT by Vivadent (Usa), Inc. — Product Code EAY

K802684 is an FDA 510(k) premarket notification submitted by Vivadent (Usa), Inc. for the device "HELIOMAT". The FDA issued a decision of Substantially Equivalent on November 24, 1980. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Vivadent (Usa), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1980
Date Received
October 28, 1980
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 Vivadent (Usa), Inc.

  • K863831 — VIVADENT FILPIN (October 14, 1986)
  • K823409 — HELIOSIT-ORTHODONTIC (January 21, 1983)
  • K813015 — HELIOSEAL (December 2, 1981)
  • K802679 — SILANIT (December 17, 1980)
  • K802682 — CONTACT SEAL (November 24, 1980)
  • K802681 — HELIOBOND (November 24, 1980)
  • K802683 — HELIOSIT (November 24, 1980)
  • K802680 — ISOPAST-DS (November 12, 1980)
  • K802685 — REOLIT (November 12, 1980)
  • K801227 — SILICAP (August 12, 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)
  • 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)
  • K802716 — DEN-MAT FIBER OPTIC HALOGEN LIGHT (November 12, 1980)
  • K801591 — FIBER OPTIC ILLUMINATOR (July 21, 1980)

FDA data resources