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510(k) Data Aggregation
K Number
K213139Device Name
SURGmatic S15 L Pro
Manufacturer
KaVo Dental GmbH
Date Cleared
2021-12-21
(85 days)
Product Code
EGS, EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
KaVo Dental GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SURGmatic S15 L Pro handpiece is intended for:
- Oral, jaw and facial surgery
- Tooth extraction procedures
- Root resection
- Osteotomy
- Removal of carious material
- Tooth, cavity and crown preparations
- Processing of fillings
The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.
Device Description
The electrical-driven SURGmatic S15 L Pro handpieces in accordance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for use by a trained professional in the field of general dentistry only. The device is an electrically driven handpiece that is reusable and provided with a fiber optic light system. The electrical motor includes the light source and the SURGmatic S15 L Pro handbiece is provided with a fiber optic light transmitter to transport the light to the bur side. DIN EN ISO 14457 requlates the minimum illuminance. The dental handpieces can be sterilized in a steam sterilizer (autoclave). SURGmatic handpieces equipped with a handpiece connector in accordance with ISO 3964 are connected to a treatment unit by means of a hose and the electrical motor and receive the energy for the gear, cooling water and air for conservative dental treatment as well as the light for illumination of the operation area through corresponding output openings. Burs in accordance with ISO 1797-1 must be used with the SURGmatic handpieces. Based on the INTRAmatic connection that meets the ISO 3964 standard, the SURGmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The SURGmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.
The electrical motor rotates with an idle speed of 40.000 1/min and the gear ratio of the SURGmatic S15 L Pro instrument amounts to 1:5 (exactly 1:4,71).
The bur is held in the rotating head drive with the help of a collet and can be released by a push-button mechanism. DIN EN ISO 14457 requlates the minimum extraction force of the bur.
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