# K992512: Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation Corporation NTR-3.3 MM Self-Tapping HA Coa

- Pathway: 510(k) (Traditional)
- Applicant: Imcor
- Decided: Nov 1, 1999 after 97 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.
320 later devices descend from it; 3 cite it directly.
0 of 321 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
- K032351: The Maestro System 3.0MM Diameter Implant (2003), 313 descendants of its own
- K041938: Maximus OS (Overdenture System) (2004), 271 descendants of its own
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own

## Indications for use
The Altiva implant sizes are for widths 3.3mm, 4.00mm, and 5.00mm. All widths come in lengths of 10mm, 11.5mm, 13mm and 15mm. Altiva implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The Altiva implants can be placed with or without issue reflection. The Altiva Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The Altiva Implant is designed to be placed in immediate function with a temporary. All components are to be used as labeled. Components are not intended to be bent by the clinician.

Source page: https://510kreport.com/device/K992512
Methodology: https://510kreport.com/methodology