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510(k) K860971

DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) by Den-Mat Corp. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1986
Date Received
March 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
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)
  • K852630 — DEN-MAT PAINT-ON RUBBER DAM (December 18, 1985)

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