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510(k) K945535

GLENROE ORTHO-SIL by Glenroe Technologies — Product Code EGD

K945535 is an FDA 510(k) premarket notification submitted by Glenroe Technologies for the device "GLENROE ORTHO-SIL". The FDA issued a decision of Substantially Equivalent on January 27, 1995. The device falls under product code EGD (Wax, Dental, Intraoral), a Class I device regulated under 21 CFR 872.6890. Glenroe Technologies has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1995
Date Received
November 14, 1994
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 Glenroe Technologies

  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • K932920 — GLENROE PLASTIC BRACKET (August 24, 1993)
  • K931462 — GLENROE CHAIN (July 22, 1993)
  • K924140 — TUFF TIES (April 27, 1993)
  • K924139 — GLENROE ORTHO SEPS (April 8, 1993)
  • K924211 — EJECTOR (March 31, 1993)
  • K924993 — GLENROE BAND SEATING CONTOURING INSTRUMENT (November 25, 1992)

Other clearances for product code EGD

  • K020009 — BRACE EZE (February 11, 2002)
  • 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)
  • K895563 — PEMACO BITE WAX SHEETS (November 6, 1989)
  • K895562 — PEMACO 2000 INTRAORAL DENTAL WAX (November 6, 1989)

FDA data resources