# K120530: Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental Abutment System / Dentin Restoration S

- Pathway: 510(k) (Traditional)
- Applicant: Dentin Implants Technologies, Ltd.
- Decided: Jul 5, 2012 after 134 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
Longest line of descent: 10 generations back to K960026 (1996). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 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 2.
- K003191: Mis Implant System Decive, Mis Implants Technologies, Ltd. (2001) Summary page 2.
- K103089: Seven Implants; Biocom Implants; Lance Implants, Mis - Implant Technologies, Ltd. (2011) Summary page 2.
- K080162: Uno - One Piece Screw-Type Dental Implant, Mis Implants Technologies, Ltd. (2008) Summary page 2.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 2.
- K062566: Nobelreplace Tapered Conical Connection, Nobel Biocare USA, LLC (2006) Summary page 2.
- K081396: Swissplant Dental Implant System, Implant Direct, LLC (2009) Summary page 2.
- K090347: Camlog Abutments PS, Altatec GmbH (2009) Summary page 2.

## Indications for use
DENTIN® Dental Implants 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's chewing function. DENTIN® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: CLASSIC, RAPID, PRESTIGE. One Stage Implants: ONE PIECE DENTIN® ONEPIECE Implants 3.0 mmd are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.

Source page: https://510kreport.com/device/K120530
Methodology: https://510kreport.com/methodology