# K212538: DESS Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Dec 14, 2021 after 124 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: 13 generations back to K894595 (1990). 145 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142260: NobelActive, Nobel Biocare AB (2015) Summary page 4.
- K140878: Straumann Bone Level Tapered Implant, Straumann USA, LLC (2014) Summary page 4.
- K171784: Straumann Dental Implant System, Straumann USA, LLC (2018) Summary page 4.
- K212125: Nobel Biocare Dental Implant Systems Portfolio - MR Conditional, Nobel Biocare AG (2021). Cleared while this submission was under review Summary page 4.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 4.

## Most influential descendants
- K251280: DESS® Dental Implants (2025), 0 descendants of its own

## Indications for use
DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate. Implants of diameter 3.0 mm, 3.3 mm and 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth.

Source page: https://510kreport.com/device/K212538
Methodology: https://510kreport.com/methodology