Home / 510(k) Clearances / K152247

510(k) K152247

ATLANTIS Crown by Dentsply International, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2016
Date Received
August 10, 2015
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 Dentsply International, Inc.

  • K160207 — ATLANTIS ISUS Implant Suprastructures (September 21, 2016)
  • K160232 — Disposable Barrier Sleeves and Covers (June 7, 2016)
  • K151439 — ATLANTIS ISUS (February 19, 2016)
  • K151039 — ATLANTIS Abutment for NobelActive 3.0 (January 14, 2016)
  • K151619 — Prime&Bond Elect Universal Dental Adhesive (October 30, 2015)
  • K150535 — Cavitron Touch Ultrasonic Scaling System (June 16, 2015)
  • K142178 — PROROOT MTA WHITE, PROROOT MTA GRAY (February 26, 2015)
  • K131907 — RAYPEX 6 (January 31, 2014)
  • K131644 — ANKYLOS SYNCONE ABUTMENT 5(DEGREE) (January 22, 2014)
  • K132145 — MTM(R) CLEAR ALIGNER (October 11, 2013)

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)