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510(k) Data Aggregation
K Number
K052733Device Name
ALMITECH INC. DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2005-12-22
(84 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ALMITECH INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The implant system is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain over dentures by means of o-ring abutments or bar-attachments
Device Description
Almitech is an Endosteal Root-form (Cylindrical) Implant. The implant system consists of multiple components that are precision-machined and are manufactured from grade-4 pure titanium or a medical grade titanium alloy.
Implants: Almitech implant (See attachment 5, 6, 7) is intended for cither single-stage or two-stage surgical placement. Implant consist of fine pitch threads with 60° profiles, spherical tips and have two cutting grooves that give the implant its self-tapping feature. The outside surface is sandblasted with calcium phosphate abrasive to create surface roughness about Ra= 70μIN. (See Blasted surface information Attachment 1, 2, 3, 4). The inside of the implant consists of 8° Morse taper with three cutouts to drive it in place and provide positioning to abutment and threaded hole to deliver abutment in to place.
Cover screw / healing caps: The cover screws and healing caps (See attachment 8, 9) are manufactured from grade 4 titanium and are placed in the implant using a Hex Tool. Using the 1.25mmD Hex Tool, by carrying the cover screw/healing cap to the surgical site thread it into the implant. Suture the soft tissue over the implant or around the cover screw (healing cap) or transmucosal neck. The cover screw/ healing cap keeps free from ingrowth of bone and soft tissue as well accumulating debris by occluding the internal surface of the implant. The parts are found freely floating inside a sterile individual Tyvek pouches.
Abutment systems and superstructures: The abutment (See attachment 10, 11) selection process occurs at the start of the prosthetic procedure and is dependent on the measurement of gingival thickness. After adequate osseo-integration the implants should be uncovered if necessary and the cover screw should be removed. The internal part of the implant irrigated. freed from debris and dried. The appropriate abutment should be placed, by using an inserting driver (1.25mmD Hex Tool) and a torque wrench applying 30 Ncm of torque. Once the abutment is fit on the implant, it delivers maximum stability with the use of the torque wrench.
Solid Abutments do not have to be modified but can be, and if it is necessary to modify the abutments, carbide or a diamond bur can be used with copious irrigation.
Abutments are not to be over-prepared, taking into consideration retention of restoration and strength of the abutment. It is not recommended to modify the abutment at the junction with implant.
Surgical Instruments: The range of instruments made available as part of the Almitech Inc. Dental Implant System include: drills, adapters, implant inserts, screw drivers, torque ranges, ratchets and metal cassettes for sterilization.
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