# K981516: Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub

- Pathway: 510(k) (Special)
- Applicant: Sterngold/Implamed
- Decided: May 11, 1998 after 13 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
No predicates in its family tree.
1,066 later devices descend from it; 4 cite it directly.
0 of 1,067 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K984104: Iti Dental Implant System (1999), 1,043 descendants of its own
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) (2000), 942 descendants of its own
- K992937: Dental Implant (2000), 735 descendants of its own
- K023113: Replace Tiunite Endosseous Implant (2002), 689 descendants of its own
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own

## Indications for use
The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentuous and partially dentate patients in the maxillae and mandible. Implant retsined restoration may consist of single crowns or bridges as well as complete or partial déntures.

Source page: https://510kreport.com/device/K981516
Methodology: https://510kreport.com/methodology