Implant, Endosseous, Root-Form
Regulation 872.3640
19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
Top companies in DZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare AB | 33 | 37 |
| Biomet 3i | 11 | 52 |
| Nobelpharma AB | 52 | 0 |
| Zimmer Dental, Inc. | 19 | 30 |
| Straumann USA | 35 | 9 |
| Implant Innovations, Inc. | 37 | 4 |
| Steri-Oss, Inc. | 40 | 0 |
| BioHorizons Implant Systems, Inc. | 26 | 12 |
| Minimatic Implant Technology | 34 | 0 |
| Implant Center of the Palm Beaches | 32 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
3.7 mm x 10 mm
diameter 3.5 mm
Catalog #TMTB10
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading a Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
4.1 mm x 13 mm
diameter 3.5 mm
Catalog #TMT4B13
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
4.1 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMT4B11
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loadin Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
4.1 mm x 10 mm
diameter 3.5 mm
Catalog #TMT4B10
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
3.7 mm x 13 mm
diameter 3.5 mm
Catalog #TMMB13
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
3.7 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMMB11
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading afte Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
3.7 mm x 10 mm
diameter 3.5 mm
Catalog #TMMB10
Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conve Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
4.1 mm x 13 mm
diameter 3.5 mm
Catalog #TMM4B13
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
4.1 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMM4B11
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading aft Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
4.1 mm x 10 mm
diameter 3.5 mm
Catalog #TMM4B10
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after Terminated |
DZE | K112160 |
| Jan 6, 2016 | Biomet 3i, LLC BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK614 Terminated |
DZE | K934126 |
| Jan 6, 2016 | Biomet 3i, LLC BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655
BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the Terminated |
DZE | K934126 |
| Dec 7, 2015 | BioHorizons Implant Systems Inc RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R),
Dental Implant Terminated |
DZE | K073268 |
| May 12, 2015 | BioHorizons Implant Systems Inc Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only,
Product Usage Usage:
Surgical instruments used in preparation for dental implant placement Terminated |
DZE | K071638 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x13mm, Article No. 36713. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x10mm, Article No. 36711. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x8mm, Article No. 36710. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x13mm, Article No. 36708. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x11.5mm, Article No. 36707. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x10mm, Article No. 36705. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x8mm, Article No. 36704. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC NP 3.5x13mm, Article No. 36702. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC NP 3.5x11.5mm, Article No. 36701. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC NP 3.5x10mm, Article No. 36700. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. Terminated |
DZE | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| 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 | K023113 K050258 +1 |
| Apr 10, 2015 | Biomet 3i, LLC OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm.
Dental Implants. Terminated |
DZE | K130949 |
| Apr 10, 2015 | Biomet 3i, LLC OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm.
Dental Implants. Terminated |
DZE | K100724 |
| Apr 10, 2015 | Biomet 3i, LLC 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm
Dental Implants. Terminated |
DZE | K122300 |
| Mar 12, 2015 | Southern Implants, Inc MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant.
Product Usage:
The MAX Implant is intended to be implanted in the upper and Terminated |
DZE | K071161 |
| Dec 22, 2014 | Instradent USA, Inc. Neodent Titamax WS Cortical Implant 4.0 x 5 mm
(Endosseous dental implant)
Article Number: 109.604
Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide Terminated |
DZE | None listed |
| Nov 6, 2014 | Straumann USA, LLC Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim
Article Number: 021.4308
Product Usage:
Dental implants are intended for surgical placement in maxillary and/or mandibular arches Terminated |
DZE | K121131 |
| Oct 30, 2014 | Zimmer Dental Inc Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform
Part No. TSV4B10
Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform
Part No. TSV4B11
The Tapered Screw-Vent Implants Terminated |
DZE | K072589 |
| Oct 30, 2014 | Zimmer Dental Inc Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135.
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses fo Terminated |
DZE | K093164 |
| Oct 23, 2014 | Straumann USA, LLC Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim
Article Number: 021 .5308
Dental implants are intended for surgical placement in maxillary and/or mandibular arches to pr Terminated |
DZE | K140878 |
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