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510(k) Data Aggregation
K Number
K200992Device Name
S.I.N. Dental Implant System
Manufacturer
S.I.N.-Sistema de Implante Nacional S.A.
Date Cleared
2020-11-17
(216 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
S.I.N.-Sistema de Implante Nacional S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. This submission adds the following components to the S.I.N. Dental Implant System:
Tryon CM Conical implants, Tryon CM Cylindrical implants, Tryon CM Cylindrical Body and Conical Apex implants, and Strong SW implants, each with a Morse taper connection and the identical acidetched endosseous surface cleared in in K170392;
Strong SW Plus implants with a Morse taper connection and an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M) identical to the coating cleared in K170392:
conventional angled abutments and healing caps with a Morse taper connection that are compatible with the Strong SW CM implant line cleared in K170392;
conventional angled abutments and healing caps with a Morse taper connection that are compatible with the subject device Tryon CM implant lines, the subject device Strong SW/Plus implant lines, and the Unitite implant line cleared in K17039;
healing caps with a Morse taper connection that are compatible with the Unitite Compact implant line and the Unitite Slim implant line cleared in K170392;
healing caps with an external hex (HE) or internal hex (HI) connection that are compatible with the Strong SW HE, the Tryon HE implant lines, and the Strong SW HI implant lines, cleared in K170398;
abutment screws for use with the angled abutments or healing caps.
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