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510(k) K961472

DENTAL DAM SILICONE by Worldwide Dental, Inc. — Product Code EIE

K961472 is an FDA 510(k) premarket notification submitted by Worldwide Dental, Inc. for the device "DENTAL DAM SILICONE". The FDA issued a decision of Substantially Equivalent on August 7, 1996. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Worldwide Dental, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1996
Date Received
April 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

Other clearances by Worldwide Dental, Inc.

  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K940785 — MOUTH PROPS (October 5, 1994)
  • K770407 — SHIELD, DENTAL X-RAY, PROTECTIVE (March 15, 1977)

Other clearances for product code EIE

  • K182118 — armor LC (May 3, 2019)
  • K151945 — Triumph Resin Dam (February 18, 2016)
  • K050318 — BARI-KAD PACKING DEVICE (March 4, 2005)
  • K043301 — GC TION GINGIVAL PROTECTOR (January 25, 2005)
  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)

FDA data resources