# K980620: Dentatus Mti  Modular Transitional Implants and Prosthetic System

- Pathway: 510(k) (Traditional)
- Applicant: Dentatus USA, Ltd.
- Decided: May 15, 1998 after 86 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: 1 generation back to K781060 (1978). 11 ancestors in all.
322 later devices descend from it; 3 cite it directly.
0 of 334 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 1.
- K820013: Titanium Implant Devices, Bofors Nobelpharma, Inc. (1982) Summary page 1.
- K781060: Monoject Endosseous Dental Implant, Sherwood Medical Industries (1978) Summary page 1.
- K861426: Screw-Vent (TM) Implant/Endosseous Screw Implant, Core-Vent Corp. (1986) Summary page 1.
- K892124: Impla-Med Implant System, Impla-Med (1989) Summary page 1.
- K921854: Impla-Med Hex Screw Implants, 18 and 20 MM, Impla-Med (1992) Summary page 1.
- K852802: Denar Dental Implant, Denar Corp. (1985) Summary page 1.
- K884845: Steri-Oss, Denar Corp. (1989) Summary page 1.
- K891346: Artech Type SS Submerged Screw Implant, Artech Corp. (1989) Summary page 1.
- K895267: Artech Type SS-HA Submerged Screw Implant, Artech Corp. (1990) Summary page 1.
- K915375: Odontit Osseointegrated Implants System, Odontit Systeme (1992) Summary page 1.

## Most influential descendants
- K030614: 3I Dental Implants (2003), 319 descendants of its own
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own
- K051189: Prevail Dental Implants (2005), 317 descendants of its own
- K051461: 3I Osseotite Dental Implants (2005), 312 descendants of its own
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite (2007), 211 descendants of its own

## Indications for use
Intended to be placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. Examples: Support anchors for temporary restorations during the healing and osseointegration process of permanent implants. Immediate loading temporary abutments for repairing failing tooth and implant suported restorations. Transitional supports for immediate replacement of missing teeth. Provide assistance in case planning, implant position alignments, and interim anchor foundations.

Source page: https://510kreport.com/device/K980620
Methodology: https://510kreport.com/methodology
