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510(k) Data Aggregation
K Number
K200329Device Name
IDCAM Dental Implants
Manufacturer
Date Cleared
2021-04-22
(437 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Implants Diffusion International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IDCAM 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. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They 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
The ID CAM Dental Implant is a tapered conical implant system with two designs. IDCAM M (with mini-threads), and IDCAM ST. IDCAM ST has large flat threads at the top and sharp threads at the bottom and comes in diameters of 3.7, 3.9, 4.2 and 5.2 mm. Lengths of 9.4, 11.4, and 14.4 mm are available. The IDCAM M has mini-threads at the top and with sharp threads below. It comes in 4.2, and 5.2 mm diameter with lengths of 8.5,9.4, 11.4, and 14.4mm. The bottom of both IDCAM designs is convex.
All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface.
ID CAM abutments for single unit restorations are all attached by Morse taper fit as well as a screw. Morse taper cone straight abutments come in 3.6 and 4.2mm diameter with gingival heights of 1.4, 3, and 5mm. Morse taper cone shouldered straight abutments come in 5.4mm diameter at the upper platform with a 3.6mm diameter at the platform and gingival heights of 1.3, 2.2, 3.2, and 5mm. Morse taper angled cone abutments come in 7°, 15°, and 23° angles in diameters of 3.6 and 4.2 and gingival heights of 1.4 (7° only) or 1.63 (15° and 23°), 3, and 5mm. Morse taper angled cones abutments with shoulder come in 7°, 15°, and 23° angles in a diameter of 5.4 at the upper platform with a 3.6mm diameter at platform bottom and gingival heights of 0.9, 3, and 5mm in 7°, and gingival heights of 0.9, 2.35, 3.30, and 5.03mm in 15°, and 23°.
PLAN abutments in 5.4mm diameter at shoulder top with a 3.6mm diameter at shoulder bottom and come in gingival heights of 1.5 and 3mm and there are straight, 15°, and 23° versions. Plan abutments can be used for single or multiple unit restorations but are not used for removable prostheses.
Straight IDUnit abutments, angled IDUnit abutments, IDLoc abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. IDLOC is 3.6mm diameter at platform and comes in gingival heights of 2.5, and 7.5 mm. Ball attachments are in 3.5 diameter and come in gingival heights of 1, 2.5, 4, or 6mm. Straight IDUnits are in 3.6mm diameter with 4.9mm diameter at top of shoulder and come in gingival heights of 1, 2.5, 4 or 6 mm. 17° angled IDUnits come in 3.6mm diameter with 4.9mm diameter at top of shoulder and in a gingival heights of 1.35,3.02 or 5 mm. 30° angled IDUnits come in 3.6mm diameter with a 4.9mm diameter at top of shoulder and in a gingival heights of 1,3.01 or 5 mm. Straight and angled IDUnit mounted dentures can only be removed by the dentures mounted on IDLoc or ball attachments can be removed by the patient.
Provisory abutments are temporary use abutments which allow placement of a temporary restoration. These come in 3.6mm diameter and varieties of nonrotational (4.8mm diameter at top of shoulder, gingival height of 1.5mm and post height of 7.5mm), nonrotational tall (4mm diameter at top of shoulder, gingival height of 1.5mm and post height of 12.5mm), rotational (gingival height of 1.5mm and post height of 7.5mm) and provisory IDUnit (4.9mm diameter at the base and a post height of 10.5mm).
Healing caps are temporary use abutments used during the healing phase which come in different gingival heights shapes in order to account for tissue thickness differences and space differences. Cylindrical shape healing caps come in diameters of 3.2mm with heights of 3.5 and 5mm, 4 & 5 mm with heights of 2, 4, 6, and 8mm. Conical profile healing caps come in 3.6mm diameter at the platform with a 6mm cone top diameter and 4mm gingival height, or a 3.6mm diameter at platform with a 6mm cone top diameter and gingival height of 6mm. There is also a healing cap for the IDUnit.
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