# K063341: 3I Osseotite Certain Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Apr 30, 2007 after 175 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K925765 (1993). 61 ancestors in all.
209 later devices descend from it; 15 cite it directly.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.
- K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification, Implant Innovations International, Inc. (1995) Summary page 1.
- K972444: 3I Innovative Implants and Cover Screws, Implant Innovations, Inc. (1997) Summary page 1.
- K980549: Osseotite Dental Implant System, Implant Innovations, Inc. (1998) Summary page 1.
- K983347: Osseotite Dental Implants, Implant Innovations, Inc. (1999) Summary page 1.
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 1.
- K031475: Osseotite NT Certain Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants, Implant Innovations, Inc. (2003). Our reading of the summary gave K031362, FDA’s number for Lac-Mac Limited Innerbloc Various O.R. Drape Based on the… (Lac Mac, Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “3i OSSEOTITE Certain Dental Implants”.
- K041402: Modification to Osseotite NT Certain Implants, Implant Innovations, Inc. (2004) Summary page 1.
- K051189: Prevail Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.
- K051461: 3I Osseotite Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K030164: Non-Sterile, Powder-Free, Polymer Coated, Natural and/or Violet and Black Color, Latex Examination Gloves with Protein, Yty Industry (Manjung) Sdn Bhd (2003). Our reading of the summary gave K030164, FDA’s number for Non-Sterile, Powder-Free, Polymer Coated, Natural and/or… (Yty Industry (Manjung) Sdn Bhd). Its FDA name has none of the distinctive words the summary uses for the device it names, “3i OSSEOTITE Certain Dental Implants”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own
- K100724: Osseotite II Model Xifossxxx (2011), 27 descendants of its own
- K083480: Inclusive Zirconia Abutment Blanks (2009), 27 descendants of its own

## Recalls of this device
- Aug 8, 2016 · Class II · Z-2845-2016: Product was incorrectly packaged.
- Nov 25, 2015 · Class II · Z-2520-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2485-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2516-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2488-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2483-2016: Pouches may not have been sealed during packing.
- Jun 10, 2013 · Class II · Z-2208-2013: One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
- Aug 3, 2012 · Class II · Z-0119-2013: Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
- Mar 23, 2012 · Class II · Z-2158-2012: Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover sc
- Nov 4, 2011 · Class II · Z-1828-2012: On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.

## Indications for use
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, > 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

Source page: https://510kreport.com/device/K063341
Methodology: https://510kreport.com/methodology