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510(k) K972775

FASTDAM by Interdent, Inc. — Product Code EIE

K972775 is an FDA 510(k) premarket notification submitted by Interdent, Inc. for the device "FASTDAM". The FDA issued a decision of Substantially Equivalent on February 27, 1998. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Interdent, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1998
Date Received
July 24, 1997
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 Interdent, Inc.

  • K823457 — NON-PRESSURE AUTOCLAVE FOR STERILIZATION (February 23, 1983)

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