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510(k) K945077

INSTRUMENT,FILLING,PLASTIC,DENTAL by Worldwide Dental, Inc. — Product Code EKJ

K945077 is an FDA 510(k) premarket notification submitted by Worldwide Dental, Inc. for the device "INSTRUMENT,FILLING,PLASTIC,DENTAL". The FDA issued a decision of Substantially Equivalent on November 30, 1994. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Worldwide Dental, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1994
Date Received
October 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Worldwide Dental, Inc.

  • K961472 — DENTAL DAM SILICONE (August 7, 1996)
  • K940785 — MOUTH PROPS (October 5, 1994)
  • K770407 — SHIELD, DENTAL X-RAY, PROTECTIVE (March 15, 1977)

Other clearances for product code EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K943820 — STAT PAK (November 2, 1994)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)
  • K925115 — AMD DENTIST AND HYGIENIST KITS (July 5, 1994)

FDA data resources