# K013067: Frialoc Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Apr 9, 2002 after 209 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: 3 generations back to K894595 (1990). 12 ancestors in all.
568 later devices descend from it; 2 cite it directly.
0 of 581 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925760: Branemark System Conical Self-Tapping Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- K992937: Dental Implant, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K945847: Frialit (R)-2 Stepped Screw with Deep Profile Surface, Friatec Medical Inc., USA (1996) Summary page 1.

## Most influential descendants
- K021318: Xive Dental Implant System (2002), 547 descendants of its own
- K032158: Xive Dental Implant System Multiple (2003), 542 descendants of its own
- K024004: Xive Transgingival Dental Implant System (2003), 425 descendants of its own
- K032284: Xive TG Dental Implant System (2003), 394 descendants of its own
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own

## Indications for use
The FRIALOC Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for freestanding maxillary and mandibular bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two FRIALOC transgingival threaded implants. In the edentulous maxilla, 2 minimum of four FRIALOC transgingival threaded implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four FRIALOC transgingival threaded implants are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

Source page: https://510kreport.com/device/K013067
Methodology: https://510kreport.com/methodology