(90 days)
The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- Astra Tech Implant System® Multi Base Abutment EV, 4.8 mm, max 30°
- DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
- 3i OSSEOTITE®
- Astra Tech OsseoSpeed™
- Neodent Grand Morse
- NobelReplace® Conical
- NobelReplace® Trilobe
- Nobel Brånemark System®
- Straumann BLX Implants
- DESS Dental Multi Unit Abutments, Angled, 3.4-6.5 mm, max 30°
- NobelActive® NobelParallel Conical
- Straumann® Bone Level
- Zimmer Screw Vent® and Tapered Screw-Vent®
- Dentium SuperLine® Abutments, 4.5-5.5 mm, max 30°
- Keystone Multi Unit Abutment, 4.8 mm, 0°
- Implant Direct GPS® Angled Abutment, 5.0 mm, max 30°
- MIS Multi-unit Abutments, 4.8 mm
- C1 Conical Connection Implant System, max 30°
- V3 Conical Connection Implant System, max 30°
- Internal Hex Implant System, max 30°
- Conical Connection, max 30°
- Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
- Nobel Biocare Brånemark Multi-Unit Abutment, 4.8 mm, max 17°
- Nobel Biocare Multi-Unit Abutment Plus, 4.8 mm, max 30°
- Nobel Biocare Multi-Unit Abutment, 4.8 mm, max 30°
- Nobel Biocare Multi-Unit Abutments for Straumann and Astra Tech System, 4.8mm, max 30°
- Nobel Biocare Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
- Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
- Paltop Multi Unit Abutment, 5.0 mm, max 17°
- Southern Compact Conical Abutments, 4.8 mm
- MAX Implant System, 0°
- Provata Implant System, max 30°
- Deep Conical (DC) Implants, 0°
- Piccolo Implants, 0°
- External Hex Implants, max 30°
- Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
- Straumann® Screw Retained Abutment, 4.6 mm, max 30°
- Zimmer Angled Tapered Abutments, 4.5 mm, max 30°
The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.
Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.
- Type A: Intended to act as a supporting structure to facilitate the attachment of removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
- Type B: Intended to act as a supporting structure to facilitate the attachment of fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)