# K121873: Avinent Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Avinent Implant System S.L.
- Decided: Dec 11, 2013 after 532 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: 9 generations back to K960026 (1996). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073268: Biohorizons Internal Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 1.
- K041661: Nobel Biocare Endosseous Implants, Nobel Biocare Uas, Inc. (2004). Our reading of the summary gave K041681, FDA’s number for Atricure Dissector (AtriCure, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nobel Biocare Endosseous Implants”. Summary page 1.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 1.

## Indications for use
The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. Implants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied. Specific indications for small diameter (03.3 mm implants): Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary incisors or mandibular central and lateral incisors.

Source page: https://510kreport.com/device/K121873
Methodology: https://510kreport.com/methodology