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510(k) K240240

Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems by Prismatik Dentalcraft, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2024
Date Received
January 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Prismatik Dentalcraft, Inc.

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  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)
  • K250223 — BruxZir® Esthetic NOW (February 25, 2025)
  • K241493 — Glidewell™ 3DP Denture Base Resin (September 12, 2024)
  • K231940 — BruxZir® NOW SRC (May 15, 2024)
  • K240882 — BruxZir® Esthetic (May 1, 2024)
  • K240574 — BruxZir® Radiant (March 20, 2024)

Other clearances for product code NHA

  • K251434 — Healing Abutment System (March 4, 2026)
  • K251515 — Solidex® Ti-Links and Screws (February 10, 2026)
  • K251427 — EK MULTI ANGLED 30 ABUTMENT (January 29, 2026)
  • K243732 — Multi-Unit DAS System (January 29, 2026)
  • K253253 — IPDmilled Blanks (January 22, 2026)
  • K253315 — Straumann Variobase Abutments XC for Bridge/Bar (January 22, 2026)
  • K252727 — Neodent InLab Validated Workflow (January 7, 2026)
  • K253341 — Custom Abutments AS (December 23, 2025)
  • K253312 — OrangeCAD Med Abutments (December 23, 2025)
  • K252320 — SIMDA Abutments (December 18, 2025)