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510(k) K854530

PREMIUM FLEXI-TOUGH by The Hygenic Corp. — Product Code EGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
November 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Dental, Intraoral
Device Class
Class I
Regulation Number
872.6890
Review Panel
DE
Submission Type

Other clearances by The Hygenic Corp.

  • K954990 — DENTAL DAM (January 26, 1996)
  • K930764 — ENDO-ICE-PULP TESTER-THERMAL (May 27, 1993)
  • K905418 — GATES GLIDDEN DRILLS (July 25, 1991)
  • K911225 — TRAY DOUGH (April 17, 1991)
  • K905640 — SOLID CORE GUTTA PERCHA CARRIER (March 5, 1991)
  • K900301 — NOVUS BONDING AGENT (May 15, 1990)
  • K900844 — WEDJETS (April 16, 1990)
  • K894092 — DENTAL ENDODONTIC CEMENT (MODIFICATION) (January 10, 1990)
  • K881826 — ENDO-ICE (August 23, 1988)
  • K873644 — PULP PEN (October 27, 1987)

Other clearances for product code EGD

  • K020009 — BRACE EZE (February 11, 2002)
  • K945535 — GLENROE ORTHO-SIL (January 27, 1995)
  • K924024 — ORTHO WAX (November 17, 1992)
  • K923586 — BURNOUT MATERIAL (September 29, 1992)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K922380 — BITE RIM WAX (June 16, 1992)
  • K914513 — PALAVIT G (March 19, 1992)
  • K910676 — INTRAORAL DENTAL WAX (August 21, 1991)
  • K904928 — PALAVIT GLC (June 6, 1991)
  • K895562 — PEMACO 2000 INTRAORAL DENTAL WAX (November 6, 1989)