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510(k) K771974

SOLVENEX I-0 by Den-Mat Corp. — Product Code KZP

K771974 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "SOLVENEX I-0". The FDA issued a decision of Substantially Equivalent on January 12, 1978. The device falls under product code KZP (Solution, Cement Dissolving), a Class II device regulated under 21 CFR 872.3750. Den-Mat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1978
Date Received
October 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Cement Dissolving
Device Class
Class II
Regulation Number
872.3750
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 KZP

  • K920843 — TOOTH CONDITIONER (April 8, 1993)

FDA data resources