# K990342: Synocta Prosthetics

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Jul 20, 1999 after 166 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: 1 generation back to K894844 (1990). 2 ancestors in all.
696 later devices descend from it; 14 cite it directly.
0 of 699 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894844: Bonefit Implant System Accessories & Instruments, Straumann Institute, Ltd. (1990) Summary page 1.
- K943720: Iti Transversal Screwing System, The Straumann Co. (1995) Summary page 1.
- (no number) Nobel Biocare’s prosthetic accessories: named in the summary without a submission number
- (no number) Implant Innovations’ prosthetic accessories: named in the summary without a submission number
- (no number) Friatec’s prosthetic accessories: named in the summary without a submission number

## Most influential descendants
- K013798: Prosthetic Accessories to the Iti Dental Implant System (2001), 575 descendants of its own
- K012757: Iti Dental Implant System (2001), 535 descendants of its own
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System (2002), 520 descendants of its own
- K020096: Esthetic Ease Abutments for the Iti Dental Implant System (2002), 516 descendants of its own
- K033243: Iti Synocta Meso Abutments (2003), 514 descendants of its own

## Indications for use
Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and cylinders, and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cylinders provide a machined or cast inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase.

Source page: https://510kreport.com/device/K990342
Methodology: https://510kreport.com/methodology