# K162633: Custom Bars

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Jul 24, 2017 after 306 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K944964 (1995). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122424: Isus Implant Suprastructures, Dentsply International, Inc. (2013) Summary page 4.

## Indications for use
Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants. Manufacturer Implant Line Body Diameter Implant Platform Implant Direct InterActive 4.3mm, 5.0mm 3.4mm Implant Direct SwishActive 4.8mm 3.4mm Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments. Manufacturer Implant Line Implant Platform Implant Direct InterActive 3.4mm Implant Direct SwishActive 3.4mm

Source page: https://510kreport.com/device/K162633
Methodology: https://510kreport.com/methodology