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510(k) K790589

DENTURE-TIGHT by Den-Mat Corp. — Product Code EBP

K790589 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "DENTURE-TIGHT". The FDA issued a decision of Substantially Equivalent on August 10, 1979. The device falls under product code EBP (Reliner, Denture, Over The Counter), a Class II device regulated under 21 CFR 872.3560. Den-Mat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1979
Date Received
March 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reliner, Denture, Over The Counter
Device Class
Class II
Regulation Number
872.3560
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 EBP

  • K121318 — PROSOFT (June 6, 2012)
  • K101771 — RELINE-IT MODEL RELINE-IT (September 20, 2010)

FDA data resources