# K014235: Osseotite NT Dental Implants & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: May 16, 2002 after 141 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925765 (1993). 6 ancestors in all.
583 later devices descend from it; 11 cite it directly.
0 of 590 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification, Implant Innovations International, Inc. (1995) 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.
- K002475: Replace TPS Coated Implants, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K994376: Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA, Friadent GmbH (2000) Summary page 1.
- (no number) OSSEOTITE® Dental Implants and Accessories: named in the summary without a submission number

## Most influential descendants
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants (2002), 478 descendants of its own
- K062069: Atlantis Abutment for 3I Micromini Implant (2007), 361 descendants of its own
- K070833: Atlantis Abutment for Astra Implant (2007), 357 descendants of its own
- K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants (2008), 337 descendants of its own
- K031475: Osseotite NT Certain Implants (2003), 330 descendants of its own

## Indications for use
OSSEOTITE NT™ Implant System is indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient’s chewing function.

Source page: https://510kreport.com/device/K014235
Methodology: https://510kreport.com/methodology