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Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implants may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants. The Ø3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.

The Quantum Dental Implant System implants included in this submission are root form, endosseous dental implants with a Morse taper and external hex abutment interface. They are made of titanisous alloy, with three surface options. Implants are provided in both a threaded and a grooved (fin-ype) design. The implants are 3.0 mm in diameter and are available in four lengths (8, 9, 11, & 14 m(1)

Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Quantum Dental Implant System abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants, or when using any 5 mm or 6 mm length implant.

The Quantum Dental Implant System includes root form, endosseous dental implants with internal Morse taper and external hex abutment interfaces. The implants are made of titanium alloy with three surface options (RBM, acid etch, HA coated), and are provided in both threaded and a grooved (fin-type) designs. There are four sizes of the internal Morse taper (implant well), designated as the 2.0, 2.5, 2.75, and 3.0 Series. For all series, the threaded and fin-type implant designs are each provided in the following sizes: diameters of 4.5, 5.0, 5.5, and 6.0 mm, with each diameter in lengths of 5, 6, 9, 11, and 14 mm. The 2.0 Series of the threaded and fin-tvpe implant designs also include: 4.0 mm diameter in 5 and 6 mm lengths, 8.0 mm diameter implants in 5 and 14 mm lengths, and 5.0 mm diameter available only in lengths of 5 and 6 mm. The 2.5 Series of the threaded and fin-type implant designs also include 4.0 mm diameter in lengths of 5, 6, 9, 11, and 14 mm. Abutments for cement-retained prostheses are provided for each diameter implant. All abutments are made of titanium alloy. Abutments with a Morse taper interface are provided for all implant series in straight, 15° and 25° angled designs. The 2.0 Series Morse taper abutments are provided in 5 mm and 7 mm platforms; all other Series are provided in 3.5, 4, and 5 mm platforms. External hex interface abutments are provided for the 2.5. 2.75. and 3.0 Series implants in straight, 15° and 25° angled designs. The 2.5 Series hex abutments are 4 mm platform; the 2.75 and 3.0 Series hex abutments are 4.5 mm platform. Healing plugs are provided for each implant series in titanium alloy and polyethylene.

This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Quantum Versatility Implants are screw-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The Quantum Implant system is most similar the DB Precision Implant system cleared in K-853788 which is very similar to the Titanaloy submersible implant system cleared in K-830414. Like many commercial implants, the Quantum devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). Quantum Implants also are available in coated form, either hydroxyapatite or titanium plasma spray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112.