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SARTORI Implants

Craniomaxillofacial (CMF)

Palatal Distractor

ANVISA registration 80083650072

The commercial models that make up the Palatal Distractor family are defined as fixation devices, classified as long-term surgically invasive medical devices, for fixation to the maxillary bones.

Codes
4
Documents
1

Technical information

Everything the surgical team needs to know.

Overview

The commercial models that make up the Palatal Distractor family are defined as fixation devices, classified as long-term surgically invasive medical devices, for fixation to the maxillary bones.

Surgically assisted maxillary expansion is an alternative for the correction of transverse maxillary deficiencies. The anchorage type of the Palatal Distractor is bone-borne, that is, it must be fixed to the palatal process. All expansion will occur through the separation of the two maxillae, without influence on the treatment regarding the number of teeth or the patient's periodontal health. This procedure provides space to align the teeth and causes a widening of the apical base of the maxilla and the palatal vault, providing space for the tongue and proper swallowing; in addition, there is an improvement in breathing (Lima A.N. 2011).

The design and use of the distractor are based on an understanding of bone healing and of the loads and forces to which the medical device is subjected. The implant was developed to withstand distraction and compression loads; thus, it provides structural stability as well as the transmission or relief of mechanical loads on the maxillary bones.

The Palatal Distractor is manufactured from Ti-6Al-4V Titanium Alloy and consists of an adjustable distraction element body, which is activated manually, and two plates with prongs that are fixed to the bone walls of the maxilla with Microfragment Screws (ancillary components).

Indications

Transpalatal distraction is indicated to correct transverse maxillary discrepancies and dental crowding, such as: posterior crossbite, which can be unilateral or bilateral, ogival-shaped palate, loss of parabolic conformation of the dental arch (“V” shape).

Materials

Titanium Alloy ASTM F136

Components

Components and codes

4 codes available in this system. Search by code or description.

Components and codes of Palatal Distractor
Code Description ANVISA Qty
0182001-009Distrator Palatal 9 mm800836500721
0182001-018Distrator Palatal 18 mm800836500721
0182001-027Distrator Palatal 27 mm800836500721
0182001-036Distrator Palatal 36 mm800836500721

Instructions for use

Instructions for use and documents

Official PDF files, with revision and ANVISA registration.

Quote

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