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Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.

The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Titanium Coping, Temporary Cap, abutment screws, the Smileloc Activator (or Smileloc Remover) (all cleared under K160786) and Smilekey (cleared under K180609). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable. The Rodo Abutment System eliminates the need for an access hole on the occlusal surface of a screw-retained restoration and also eliminates the possibility of prosthetic screw loosening. The Smilekey is an induction heating device for dental prosthesis removal of the Smileloc Sleeve in the Rodo Abutment System. The Smilekey was cleared as an accessory to the Abutment System in K180609, and there have been no changes to the Smilekey since this clearance. The Rodo Abutment is provided in five series designs (100 F, 200 P, 300 S, 400 M, 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 300 S series is designed for limited occlusal space and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 3.0 mm to 6.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.

The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). It is used to deliver induction energy to the Smileloc Sleeve. The Smilekey consists of a tip and handle that uses induction (alternating electromagnetic field) to deliver precise energy to the Smileloc. Only the end of the tip is inserted inside the patient's mouth while the handle is hand-held by the operator. The Smilekey is powered by a rechargeable lithium battery inside the handle. The handle also contains an electronic control board that regulates the entire operation, including LED indicators that let the operator know when energy is being applied to the Smileloc Sleeve and when the unlocking procedure has been completed.