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510(k) K935718

JEDENTAL VLC DENTAL CURING LIGHT by Jedental Co., Inc. — Product Code EAY

K935718 is an FDA 510(k) premarket notification submitted by Jedental Co., Inc. for the device "JEDENTAL VLC DENTAL CURING LIGHT". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Jedental Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
November 30, 1993
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 Jedental Co., Inc.

  • K933612 — JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) (February 24, 1994)
  • K934073 — JEDENTAL GLASS IONOMER CEMENT AND LINER (January 26, 1994)
  • K935727 — P&FS PIT AND FISSURE SEALANT (January 21, 1994)
  • K933656 — JEDENTAL PSROFILL SELF-CURE COMPOSITE (November 17, 1993)
  • K933554 — JEDENTAL ZINC CEMENT IMPROVED (November 1, 1993)
  • K933543 — ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) (November 1, 1993)
  • K931880 — PROFILL LC COMPOSITE (July 8, 1993)

Other clearances for product code EAY

  • K953191 — MODEL A15-101 (September 5, 1995)
  • K953192 — MODEL A15-103 (September 5, 1995)
  • 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)
  • K801591 — FIBER OPTIC ILLUMINATOR (July 21, 1980)

FDA data resources