Nobelreplace Hexagonal Implant

• • Terminated Z-0658-2022 FDA Class II ·initiated 17 Dec 2021

  Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

• • Terminated Z-2828-2020 FDA Class II ·initiated 20 Jul 2020

  Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.

510(k) Number

K073142 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Nobelprocera Overdenture Bar

  Class II

  FDA 510(k) K132749 Active Cleared 24 Jul 2014

• Goldadapt Non-Engaging Nobelactive Np & Rp, Goldadapt Engaging Nobelactive Np & Rp

  Class II

  FDA 510(k) K083100 Active Cleared 19 Nov 2008

• Nobelrondo Dental Ceramic - Zirconia

  Class II

  FDA 510(k) K043312 Active Cleared 1 Feb 2005

• Nobelreplace Tapered Conical Connection

  Class II

  FDA 510(k) K062566 Active Cleared 6 Dec 2006

• Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM, Model 29315

  Class II

  CE/MDR FDA 510(k) K052885 Active Cleared 23 Dec 2005

• Nobelprocera Angulated Screw Channel Abutment Conical Connection

  Class II

  FDA 510(k) K132746 Active Cleared 30 Jan 2014

See all devices from Nobel Biocare USA, LLC →