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Reflect™ Dental Implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Reflect™ Dental Implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Reflect™ Implant System prosthetic components are compatible with the following implant systems. | Implant System<br>Compatibility | Implant Body Diameter<br>(mm) | Platform Diameter<br>(mm) | |---------------------------------|-------------------------------|---------------------------| | OsseoSpeed™ | 3.5 | 3.5/4.0 | | | 4.0 | 3.5/4.0 | | | 5.0 | 4.5/5.0 | | 3i Certain® | 3.25 | 3.4 | | | 4.0 | 4.1 | | | 5.0 | 5.0 | | NobelActive® | 3.5 | NP | | | 4.3 | RP | | | 5.0 | RP | | NobelReplace Conical | 3.5 | NP | | | 4.3 | RP | | | 5.0 | RP | | Tapered Screw-Vent® | 3.7 | 3.5 | | | 4.1 | 3.5 | | | 4.7 | 4.5 |

Reflect™ Implant System implants are root form endosseous dental implants with a tapered body and a grit blasted and acid etched surface intended for bone level placement. The subject device consists of five product lines (Reflect™ Aspire, Reflect™ Certus, Reflect™ Rapid, Reflect™ Recover, and Reflect™ Tapered) and three component designs (Cover Screw, Healing Abutment, and 30° Abutment). The Reflect™ implant sizes are summarized in the following table. | Reflect TM Implant System | | | | |---------------------------|-------------|-----------------|-----------------------| | Implant Line | Body Ø (mm) | Platform Ø (mm) | Implant Lengths (mm) | | Aspire | 3.5 | 3.5 | 8, 9, 11, 13, 15 | | | 4.0 | 4.0 | 8, 9, 11, 13, 15 | | | 5.0 | 5.0 | 9, 11, 13, 15 | | Certus | 3.3 | 3.4 | 8.5, 10, 11.5, 13, 15 | | | 4.0 | 4.1 | 8.5, 10, 11.5, 13, 15 | | | 4.9 | 5.0 | 8.5, 10, 11.5, 13, 15 | | Rapid | 3.5 | NP | 8.5, 10, 11.5, 13, 15 | | | 4.3 | RP | 8.5, 10, 11.5, 13, 15 | | | 5.0 | RP | 8.5, 10, 11.5, 13, 15 | | Recover | 3.5 | NP | 8.5, 10, 11.5, 13, 16 | | | 4.3 | RP | 8.5, 10, 11.5, 13, 16 | | | 5.0 | RP | 8.5, 10, 11.5, 13, 16 | | Tapered | 3.7 | 3.5 | 8.5, 10, 11.5, 13, 16 | | | 4.1 | 3.5 | 8.5, 10, 11.5, 13, 16 | | | 4.7 | 4.5 | 8.5, 10, 11.5, 13, 16 | The Reflect™ abutment sizes are summarized in the following table. Note: each abutment is provided in each platform diameter listed. | Reflect™ Implant System - Abutments | | Compatible Implants | | | |-------------------------------------|--------------------------------------|-----------------------------|---------------------------------|----------------------------| | Implant Line | Abutments | Abutment<br>Platform Ø (mm) | Implant System<br>Compatibility | Platform<br>Diameters (mm) | | Aspire | Aspire Cover Screw | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 | | | Aspire Ø 3.5/4.0 mm Healing Abutment | 3.5, 4.0 | OsseoSpeed™ | 3.5/4.0 | | | Aspire Ø 4.5/5.0 mm Healing Abutment | 5.0 | OsseoSpeed™ | 4.5/5.0 | | | Aspire 30° Abutment | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 | | Certus | Certus Cover Screw 3.4/4.1 mm | 3.4, 4.1 | 3i Certain® | 3.4, 4.1 | | | Certus Cover Screw 5.0 mm | 5.0 | 3i Certain® | 5.0 | | | Certus Healing Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | | | Certus 30° Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | | Rapid | Rapid Cover Screw | NP, RP | NobelActive® | NP, RP | | | Recover/Rapid Healing Abutment | NP, RP | NobelActive® | NP, RP | | | Rapid 30° Abutment | NP, RP | NobelActive® | NP, RP | | Recover | Recover Cover Screw | NP, RP | NobelReplace Conical | NP, RP | | | Recover/Rapid Healing Abutment | NP, RP | NobelReplace Conical | NP, RP | | | Recover 30° Abutment | NP, RP | NobelReplace Conical | NP, RP | | Tapered | Tapered Cover Screw | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 | | | Tapered Healing Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 | | | Tapered 30° Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 | Subject device implants are made of unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNS R50550, UNS R50700) Grade 4, and subject device abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject device implant surface is produced by blasting with alumina (Al2O3) powder, and etching with hydrochloric acid and sulfuric acid. After etching, the remaining acid is removed by washing with distilled water, followed by cleaning with an alkaline solution using a high temperature and high-pressure hydrothermal method.