Nobel Biocare Usa Llc

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code NHA·July 19, 2019

Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code NHA·March 16, 2018

NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.

FDA Recall

Terminated ·Nobel Biocare USA LLC·Product code DZE·November 2, 2007

Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code NDP·March 14, 2019

Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code NDP·March 14, 2019

Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZi·March 14, 2019

Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code NDP·March 14, 2019

Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013

NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

NobelReplace CC NP 3.5x10mm, Article No. 36700.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.

FDA Recall

Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015