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510(k) K770117

HYGIENIC 5 & 6 RUBBER DAM FRAME by Hygienic Dental Mfg., Co., The — Product Code EJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1977
Date Received
January 21, 1977
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)
  • K780746 — HYGIENIC RUBBER DAM FRAME (May 12, 1978)
  • K780745 — RUBBER DAM (May 12, 1978)
  • K780743 — CLAMP FORCEPS (May 12, 1978)

Other clearances for product code EJE

  • K781520 — RUBBER DAM HOLDER (October 10, 1978)
  • K780746 — HYGIENIC RUBBER DAM FRAME (May 12, 1978)