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510(k) K112160

TAPERED SCREW-VENT X IMPLANT by Zimmer Dental, Inc. — Product Code DZE

K112160 is an FDA 510(k) premarket notification submitted by Zimmer Dental, Inc. for the device "TAPERED SCREW-VENT X IMPLANT". The FDA issued a decision of Substantially Equivalent on December 14, 2011. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Zimmer Dental, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2011
Date Received
July 27, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Zimmer Dental, Inc.

  • K160398 — MRI Compatibility for Existing Zimmer Dental Implant Systems (May 17, 2017)
  • K143505 — Zimmer Patient-Specific Abutment, Internal Hex, Titanium (June 25, 2015)
  • K143528 — Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System (May 1, 2015)
  • K142572 — Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System (January 21, 2015)
  • K142082 — ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR AB (October 28, 2014)
  • K141544 — ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM (October 22, 2014)
  • K141120 — ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM (July 29, 2014)
  • K133551 — ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM (July 18, 2014)
  • K134045 — ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE I (April 25, 2014)
  • K133339 — ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCRE (March 4, 2014)

Other clearances for product code DZE

  • K251188 — UNIQA® Dental Implants System (June 25, 2026)
  • K251232 — MegaGen Zygoma Dental Implant System (June 18, 2026)
  • K250806 — Dental Implant System (June 18, 2026)
  • K260006 — INOSS System (June 17, 2026)
  • K252731 — Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implan (May 12, 2026)
  • K252031 — Adin Long Dental Implant System (March 23, 2026)
  • K253334 — ZENEX Implant System_Short (R-System) (March 16, 2026)
  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)

FDA data resources