# K980460: Onplant Orthodontic System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: May 5, 1998 after 92 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 K925771 (1993). 6 ancestors in all.
80 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925776: Branemark System Interlocking Abutment/Gold Cylind, Nobelpharma USA, Inc. (1994) Summary page 1.
- K925771: Branemark System Titanium Cover Screws, Nobelpharma USA, Inc. (1993) Summary page 1.
- K944964: Branemark System Miruscone Abutment System, Nobelpharma USA, Inc. (1995) Summary page 1.
- K925774: Branemark System Hand Instrument, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925772: Branemark System Guide Pins, Nobelpharma USA, Inc. (1993) Summary page 1.
- K935142: Dentaurum Wires, Dentauraum, Inc. (1994) Summary page 1.
- (no number) Linkow Blade Implant: named in the summary without a submission number
- (no number) Pre-amendment orthodontic wire: named in the summary without a submission number

## Most influential descendants
- K982509: Ortho Implant and Accessories (1998), 66 descendants of its own
- K031936: Osteomed Orthodontic Screw System (2004), 63 descendants of its own
- K033767: Dual Top Anchor System Screws (2004), 54 descendants of its own
- K042965: Tomas Pin (2005), 26 descendants of its own
- K060126: Absoanchor Microimplant (2006), 19 descendants of its own

## Indications for use
The Nobel Biocare Onplant Orthodontic System is an implant intended to be surgically placed subperiosteal in the palatal region of the mouth for use as an anchor for orthodontic procedures in patients who have completed skeletal growth and maturity.

Source page: https://510kreport.com/device/K980460
Methodology: https://510kreport.com/methodology