# K140878: Straumann Bone Level Tapered Implant

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Aug 20, 2014 after 135 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894595 (1990). 88 ancestors in all.
105 later devices descend from it; 9 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 5.
- K083550: Straumann Dental Implant System, Straumann USA (2009) Summary page 5.
- K121131: BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM, Straumann USA (2012) Summary page 5.
- K123784: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 5.
- K130222: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 5.
- K983742: Iti Dental Implant System, Institut Straumann AG (1999) Summary page 5.
- K071357: P.004 NC Anatomic Abutments, Institut Straumann AG (2007) Summary page 5.
- K081005: P.004 NC Cares Titanium and Ceramic Abutments, Institut Straumann AG (2008) Summary page 5.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 5.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 5.

## 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
- K183518: Preat Abutments (2019), 22 descendants of its own
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own

## Recalls of this device
- Jul 16, 2026 · Class II · Z-2935-2026: Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
- Sep 19, 2014 · Class II · Z-0117-2015: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

## Indications for use
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Source page: https://510kreport.com/device/K140878
Methodology: https://510kreport.com/methodology