Home / 510(k) Clearances / K954988

510(k) K954988

CRYSTALLESSENCE by Confi-Dental Products Co. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1996
Date Received
October 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • 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)
  • K933199 — CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL (January 6, 1994)

Other clearances for product code EBF

  • K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (March 11, 2026)
  • K254245 — ZAFIRA® (March 3, 2026)
  • K260170 — LumiCera (January 21, 2026)
  • K252465 — Any-Core (December 5, 2025)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K253236 — G-BLOCK (September 29, 2025)
  • K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (September 23, 2025)
  • K251946 — G aenial Universal Injectable II (August 29, 2025)
  • K251283 — Once-Fil Flow (June 6, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)