# K103280: Bhdental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bhdental, Ltd.
- Decided: Feb 24, 2011 after 111 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: 11 generations back to K960026 (1996). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 1.
- K081748: Oneplant Dental Implant System, Warantec Co., Ltd. (2009) Summary page 1.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 1.
- K080156: Osseospeed TM  Profile System, Astra Tech AB (2008) Summary page 2.
- K091239: Astra Tech Implant System, Astra Tech AB (2009) Summary page 2.
- K071803: Ards Dental Implants, Ards, Ltd. (2008) Summary page 2.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 2.

## Indications for use
The BHdental Implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic. devices, such as artificial teeth, in order to restore the patient chewing function. The BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K103280
Methodology: https://510kreport.com/methodology