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510(k) K920843

TOOTH CONDITIONER by Confi-Dental Products Co. — Product Code KZP

K920843 is an FDA 510(k) premarket notification submitted by Confi-Dental Products Co. for the device "TOOTH CONDITIONER". The FDA issued a decision of Substantially Equivalent on April 8, 1993. The device falls under product code KZP (Solution, Cement Dissolving), a Class II device regulated under 21 CFR 872.3750. Confi-Dental Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
February 25, 1992
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 Confi-Dental Products Co.

  • K030807 — CARIES INDICATOR (June 9, 2003)
  • K030743 — ETCHANT 40% (May 9, 2003)
  • K955329 — RESILIENCE M5 PROTECTION PLUS (March 28, 1996)
  • K955328 — CONFI-BOND (March 28, 1996)
  • K954988 — CRYSTALLESSENCE (March 8, 1996)
  • K952930 — DENTRAY II PLUS TRAY ADHESIVE (September 8, 1995)
  • K946307 — CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 26, 1995)
  • K940546 — GRANITEC IONOMER RESIN CEMENT (April 29, 1994)
  • K936070 — TREND SET 2 PLUS (February 4, 1994)
  • K935714 — CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE (January 21, 1994)

Other clearances for product code KZP

  • K771974 — SOLVENEX I-0 (January 12, 1978)

FDA data resources