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510(k) K771973

GINGITRACT by Den-Mat Corp. — Product Code EIG

K771973 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "GINGITRACT". The FDA issued a decision of Substantially Equivalent on November 7, 1977. The device falls under product code EIG (Retractor, All Types), a Class I device regulated under 21 CFR 872.4565. Den-Mat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1977
Date Received
October 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, All Types
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Den-Mat Corp.

  • K983106 — 1ST IMPRESSION (February 9, 1999)
  • K895731 — DEN-MAT CERINATE PORCELAIN (August 3, 1990)
  • K895269 — DEN-MAT LAMI-QUICK (February 22, 1990)
  • K881918 — LIGHT-CURED ZIONOMER CEMENT (July 15, 1988)
  • K875351 — DEN-MAT PORETCH (PORCELAIN ETCHANT) (March 18, 1988)
  • K872510 — DEN-MAT TENURE (August 24, 1987)
  • K870130 — DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM (February 19, 1987)
  • K864346 — REMBRANDT PORCELAIN TINTING KIT (January 7, 1987)
  • K862449 — DEN-MAT DENTIN LINK (July 22, 1986)
  • K860971 — DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) (March 25, 1986)

Other clearances for product code EIG

  • K971284 — OPALDAM (June 3, 1997)
  • K854711 — FIBRELIGHT ILLUMINATING ORAL RETRACTORS (February 25, 1986)
  • K832366 — ZOLLER BURNED LIP CONFORMER (September 26, 1983)
  • K821784 — BEACH GINGIVAL RETRACTION INSTR. TYPE B (July 6, 1982)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)
  • K761024 — RACESTYPTINE RINGS (November 19, 1976)
  • K760657 — RACESTYPTINE CORD (September 27, 1976)

FDA data resources