Home / 510(k) Clearances / K011394

510(k) K011394

LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM by Espe Dental AG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2001
Date Received
May 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

Other clearances by Espe Dental AG

  • K011154 — ELIPAR FREELIGHT (May 16, 2001)
  • K002793 — KETAC CEM U (September 26, 2000)
  • K002364 — PROTEMP H (August 10, 2000)
  • K001494 — MODIFICATION TO PROMPT L-POP (July 7, 2000)
  • K000595 — DIMENSION PENTA L (April 5, 2000)
  • K000588 — DIMENSION GARANT L, DIMENSION GARANT L QUICK (March 30, 2000)
  • K000591 — DIMENSION PENTA H, DIMENSION PENTA H QUICK (March 30, 2000)
  • K994192 — IMPREGUM PENTA M MONOSOFT (January 28, 2000)
  • K994193 — IMPREGUM PENTA DUOSOFT (January 28, 2000)
  • K994190 — IMPREGUM GARANT L DUOSOFT (January 27, 2000)

Other clearances for product code EIH

  • K253953 — IPS e.max Zirconia (March 10, 2026)
  • K254283 — BruxZir® Shaded 16 PLUS (January 30, 2026)
  • K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (January 9, 2026)
  • K252789 — Glass Ceramic (December 8, 2025)
  • K252446 — BruxZir® NOW (September 3, 2025)
  • K251593 — DenMat Multilayered Zirconia Disc (August 25, 2025)
  • K250063 — ARENA Star, Galaxy Star (July 10, 2025)
  • K250826 — Multi M Series (June 12, 2025)
  • K251084 — zirkon; structure; LFU shades, stains and glazes (June 5, 2025)
  • K250673 — CERABIEN MiLai (May 29, 2025)