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510(k) Data Aggregation
K Number
K243094Device Name
Quickdent Dental Implant System
Manufacturer
Date Cleared
2024-12-19
(80 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Quickdent Devices Private Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Quickdent Dental Implant System 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 patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted applications. Korticale TPR IH, Ossi Classic IH, Acti Fix CC and Kortifix Pro CC 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. Trabeos 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.
Korticale SP one piece implant is indicated for support and retention of fixed single tooth and fixed partial denture restorations in premolar, cuspid and incisor regions of partially edentulous jaws. Korticale SP one piece implants may be loaded immediately in the anterior mandibular arch if four implants are splinted together with a bar. Korticale SP one piece implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.
Device Description
The Quickdent Dental Implant System contains 3 designs of internal hex implants and various types of abutments as described below as well as 2 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. Additionally, a one piece implant is available. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.
Ossi Classic IH implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Ossi Classic IH comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter).
Trabecos IH implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Trabecos comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.
Korticale TPR IH are spiral internal hex implants with widely spaced threads. Korticale TPR IH comes in 3.5 and 4.2 mm diameter with lengths of 10, 12, 14 and 16mm.
Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.
Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.
Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.
Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.
Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.
Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.
Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.
Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.
Quickloc IH attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The Quickloc IH attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.
Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.
Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.
Acti Fix CC implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. Acti Fix CC comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.
Kortifix Pro CC are spiral conical implants with widely space threads. Kortifix Pro CC comes in 3.5 (NP) and 4.2 (RP) diameters in lengths of 10, 12, 14, and 16mm.
Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.
Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.
Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.
Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.
Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.
Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.
Quicksnap CC attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Quicksnap CC attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.
Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.
Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.
Korticale SP one piece implant comes in diameters of 3.5 and 4.2mm with lengths of 8, 10, 12, 14, and 16mm. The abutment portion has a 2mm gingival collar and a 7mm abutment post height above the gingival collar. Only straight models of Korticale SP are available angular correction.
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