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Sources: EU EUDAMED, US FDA
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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
4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
FDA Recall
Open, Classified
·Daavlin Distributing Company·Product code FTC·April 26, 2022
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·May 28, 2019
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
FDA Recall
Open, Classified
·Daavlin Distributing Company·Product code FTC·December 10, 2025
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]
FDA Recall
Open, Classified
·Daavlin Distributing Company·Product code FTC·April 26, 2022
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Recall
Completed
·SynCardia Systems LLC·Product code LOZ·August 1, 2023
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
FDA Recall
Open, Classified
·Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden·Product code DZE·July 25, 2022
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
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function
FDA Recall
Open, Classified
·Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden·Product code DZE·January 10, 2025
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NHA·August 9, 2019
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NHA·August 9, 2019
Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NHA·August 9, 2019
Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NHA·August 9, 2019
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·August 9, 2019
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NHA·August 9, 2019