ClearanceBrief
510(k) K050258 ยท DZE Implant, Endosseous, Root-Form

GROOVY IMPLANTS

ApplicantNobel Biocare AB, Yorba Linda, CA, US
DecisionSubstantially Equivalent, Apr 19, 2005
ReceivedFeb 3, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K050258

DateFirm and productCodeLinked 510(k)
Apr 13, 2015Nobel Biocare Usa Llc
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 arch
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arch
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
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 arch
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arch
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arch
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
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 arch
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arc
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arche
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
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
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
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 ar
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x10mm, Article No. 36700.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x11.5mm, Article No. 36701.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x13mm, Article No. 36702.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x8mm, Article No. 36704.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x10mm, Article No. 36705.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x13mm, Article No. 36708.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x8mm, Article No. 36710.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x10mm, Article No. 36711.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x13mm, Article No. 36713.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
Terminated
DZENone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Terminated
DZENone listed
Sep 19, 2008Nobel Biocare USA LLC
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 devic
Terminated
DZENone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.