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510(k) K780745

RUBBER DAM by Hygienic Dental Mfg., Co., The — Product Code EIE

K780745 is an FDA 510(k) premarket notification submitted by Hygienic Dental Mfg., Co., The for the device "RUBBER DAM". The FDA issued a decision of Substantially Equivalent on May 12, 1978. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Hygienic Dental Mfg., Co., The has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1978
Date Received
April 13, 1978
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 Hygienic Dental Mfg., Co., The

  • K780804 — HYGIENIC ANCHORINGS (June 14, 1978)
  • K780743 — CLAMP FORCEPS (May 12, 1978)
  • K780744 — BRINKER TISSUE RETRACTORS (May 12, 1978)
  • K780746 — HYGIENIC RUBBER DAM FRAME (May 12, 1978)
  • K770117 — HYGIENIC 5 & 6 RUBBER DAM FRAME (January 28, 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