Home / 510(k) Clearances / K142082

510(k) K142082

ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT by Zimmer Dental, Inc. — Product Code DZE

K142082 is an FDA 510(k) premarket notification submitted by Zimmer Dental, Inc. for the device "ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT". The FDA issued a decision of Substantially Equivalent on October 28, 2014. 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
October 28, 2014
Date Received
July 31, 2014
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)
  • 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)
  • K132258 — ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM (November 19, 2013)

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