# K972769: Opti-Max Angled Crown Post for Externally-Hexed Implants, in 15 Degree and 25 Degree Inclinations. for Implants 3.3MM, 4

- Pathway: 510(k) (Traditional)
- Applicant: Opti-Max
- Decided: Nov 13, 1997 after 112 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 later device descends from it; 1 cites it directly.
0 of 2 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
- K040205: Intra-Lock International Angled Prosthetic Abutments (2004), 0 descendants of its own

## Indications for use
The Opti-Max angled crown post for externally-hexed implants is intended to be used as an abutment for a cast crown, to be retained by cementation. The metal for this cast crown is to be composed of a compatible formulation when in contact with Ti6Al4V. If light retention is desired by the clinician zinc-oxide cement can be used, if stronger retention is desired, carboxylate cements may be used. The cast crown seated on this crown post may be single and free-standing, part of fixed bridgework, or connected to a bar structure for overdenture retention.

Source page: https://510kreport.com/device/K972769
Methodology: https://510kreport.com/methodology