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510(k) K780746

HYGIENIC RUBBER DAM FRAME by Hygienic Dental Mfg., Co., The — Product Code EJE

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
Frame, Rubber Dam
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)
  • K780744 — BRINKER TISSUE RETRACTORS (May 12, 1978)
  • K780745 — RUBBER DAM (May 12, 1978)
  • K780743 — CLAMP FORCEPS (May 12, 1978)
  • K770117 — HYGIENIC 5 & 6 RUBBER DAM FRAME (January 28, 1977)

Other clearances for product code EJE

  • K781520 — RUBBER DAM HOLDER (October 10, 1978)
  • K770117 — HYGIENIC 5 & 6 RUBBER DAM FRAME (January 28, 1977)