Search Results
Found 1 results
510(k) Data Aggregation
K Number
K152188Device Name
QUAD Dental Implants and Prostheses
Manufacturer
Date Cleared
2016-01-28
(176 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Dentack Impants Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DenTack QUAD Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone. The system also includes various accessories that attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers.
DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.
DenTack's Prostheses are identified as follows:
Metal housing
Plastic cup
Straight Multi-unit Sleeve
Straight Multi-unit Screw
Angled abutments 15° and 25°
Angled abutments 15° Large
Ball Attachments (1, 2 & 3 mm)
Direct screw platform
Straight abutments
Screw retained abutments
Straight Multi-unit abutments
Healing caps
Cover Screw
The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.
Ask a Question
Ask a specific question about this device
Page 1 of 1