# K173418: NobelParallel Conical Connection

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Feb 21, 2019 after 477 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894595 (1990). 87 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 93 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). Our reading of the summary gave K142660, FDA’s number for Antegrade LeMills Valvulotome (LeMaitre Vascular, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NobelActive®”. Summary page 6.

## Most influential descendants
- K202344: TiUltra Implants and Xeal Abutments (2020), 4 descendants of its own
- K211109: N1 TiUltra TCC Implant System (2021), 2 descendants of its own
- K220048: NobelProcera Zirconia N1 Base (2022), 1 descendant of its own
- K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (2026), 0 descendants of its own
- K252197: Nobel Biocare S Series Implants (2026), 0 descendants of its own

## Recalls of this device
- Aug 28, 2019 · Class II · Z-1851-2020: The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the 

## Indications for use
NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

Source page: https://510kreport.com/device/K173418
Methodology: https://510kreport.com/methodology