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510(k) Data Aggregation
K Number
K250778Device Name
Sil-Flow
Manufacturer
DSI Dental Solutions Ltd
Date Cleared
2025-05-23
(70 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DSI Dental Solutions Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sil-Flow is indicated for
[A] Temporary inlay and onlay treatments of the cavity
[B] Sealing of openings for implant screws
[C] Relining material for temporary crowns and bridges
[D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions
[E] Covering of the gingival margin
[F] Fixing of resin matrix during filling placement
[G] Temporary filling of cavities
Device Description
Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing.
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K Number
K200188Device Name
DSI Dental Implant System
Manufacturer
DSI Dental Solutions Ltd
Date Cleared
2020-04-01
(68 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DSI Dental Solutions Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.
Device Description
DSI Dental Implant System is an internal hex implant system with one model of implant at this time, Premium Spiral is a slightly tapered spiral internal hex implant with micro-rings at the implant neck which comes in 3.5, 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. The 6.0 diameter implant does not come in lengths of 13 or 16mm. All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface. Loc-in abutments are anodized. All types of abutments can be used with all implants. Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. The system also includes abutment fixation screws. Straight abutments come in 7, 9, or 11mm lengths and shouldered straight abutments come 1, 2, 3, or 4mm in gingival height. Wide straight shoulder abutments come in gingival heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 7, 9, 11 mm. Straight wide abutments come in lengths of 9 or 11 mm. 15° anatomic angulated abutments come in gingival heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in gingival heights of 1, 2, or 3mm. Straight multi-unit abutments, Loc-in abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Loc-in abutments come in collar heights of 0.5, 1, 2, 3, 4, 5, and 6 mm. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in gingival heights of 0.5, 1.5 mm. Overdenture abutments are used with removable dentures and partial dentures. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Multi-unit abutments are used for fixed restorations. Straight multi-unit mounted dentures can only be removed by the dentures mounted on flat abutments, overdentures or ball attachments can be removed by the patient. The UCLA is 4.5mm in diameter and is for making gold restorations which are taller than 4mm. Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in gingival heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in gingival heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in gingival heights of 2, 3, 4, and 5 mm.
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