510(k) K023113 ยท DZE Implant, Endosseous, Root-Form
REPLACE TIUNITE ENDOSSEOUS IMPLANT
| Applicant | Nobel Biocare Uas, Inc., Yorba Linda, CA, US |
| Decision | Substantially Equivalent, Sep 26, 2002 |
| Received | Sep 19, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel 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 |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC NP 3.5x10mm, Article No. 36700. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC NP 3.5x11.5mm, Article No. 36701. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC NP 3.5x13mm, Article No. 36702. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x8mm, Article No. 36704. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x10mm, Article No. 36705. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x11.5mm, Article No. 36707. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x13mm, Article No. 36708. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x8mm, Article No. 36710. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x10mm, Article No. 36711. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x13mm, Article No. 36713. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. Terminated |
DZE | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.