In the analog days of dental implant solutions, dentists and patients too often had to deal with delays and frustration arising from multiple visits and remakes.
Fast forward to today, and the spread of digital methods is helping to alleviate these issues, making life easier for labs, dentists and patients.
The benefits of localized milling are now widely recognized, and many labs already mill crowns and abutments in-house. With in-house milling, dental labs can boost their efficiency with a faster workflow, achieve higher profit margins and shorter turnaround times, and enjoy numerous other advantages.
But the process of making in-house milling a reality can be challenging. Most importantly for the US market, stringent FDA requirements must be met. Europeans, too, likely face a tougher regulatory environment.
With Elos Medtech, however, you don’t have to worry about satisfying regulatory requirements—we’ve already done that for you. The following paragraphs explain how our solution works, and how you and your practice or lab stand to benefit.
Pre-milled abutment blanks: offering benefits to patients and their providers
The precision, efficiency, and convenience with which labs can produce abutments with localized milling far exceed that of other solutions. Custom abutments result in a solution that perfectly follows the contour of the gum for a better fit and aesthetics much closer to that of natural teeth. Moreover, custom abutments are easier to clean, and result in better implant longevity.
Pre-milled abutment blanks enable dental technicians to produce custom abutments in their labs without compromising the quality and performance of the restorations. Key advantages include faster turnaround times and more control over design and production. And clinics can offer same-day chair-side restorations for less complicated restorations meaning less chair time for patients.
There is also less shipping of physical parts back and forth, reducing the likelihood of delays and shaving valuable time and cost off the process. Dental labs can mill a part in about half an hour to an hour instead of waiting a day or more.
The potential benefits to labs’ profit margins can be substantial:
- Labs have more bandwidth to take on additional projects
- Labs eliminate the time and expense of outsourcing custom abutments and other implant-related restorations
- Switching to localized milling means labs can sell premium abutments with a greater profit margin since they’re no longer paying a premium for parts
Phil Brisebois, the founder of Gravidee Dental Studio, a 100% digital dental laboratory in West Hollywood, California, explains how the pre-milled blank has improved his workflow:
Localized milling: regulations and risk mitigation
Milling methods may be similar worldwide. But different regions and countries have different regulatory regimes that labs must follow.
In the US, the FDA classifies customer-specific milling as the manufacture of a Class II medical device. Therefore, labs milling custom implant abutments with CAD/CAM technology must either commission a validated milling center, or use products with a 510(k) pre-market clearance and registration.
The reality is that some labs that mill locally in the US do not adhere to these regulations and are thus breaking the law.
In Europe, there have been fewer rules to follow and little oversight. European labs’ ability to produce custom abutments in-house without validated workflows will likely change as global regulations continue to grow stricter with time.
Liability risks are great and can be costly in cases of non-compliance. At a minimum, labs risk idle production lines, capital costs burdens, and declining employee profitability. It is therefore essential that labs work with a trusted partner—one who already has a fully validated localized milling solution.
Safety and flexibility with a fully validated, open workflow
With Elos Medtech's FDA-cleared list of pre-approved workflows between CAD, CAM, and devices, labs do not need to register as medical device manufacturers—Elos Medtech is the designated medical device manufacturer creating the components.
Using our pre-milled blanks, labs perform the end-stage patient adjustments themselves and enjoy the flexibility and freedom to choose in-lab milling that’s equivalent to using a validated milling center.
Furthermore, our 510(k) clearance applies to our entire Elos Accurate® product line, so working with Elos Medtech means enjoying the assurance of a fully compliant product line.
Brisebois relates his experience with Elos Medtech pre-milled blanks:
Flexible, open in-lab milling components
We use standardization in our medical devices for less downtime and more control. Our pre-milled holder is compatible with an array of brands, and the modular design means parts can be easily and inexpensively replaced on demand.
Our solution uses the same screw head support as the original implant manufacturer for fewer "extra" parts, and changing blanks requires only one tool. Our blanks are laser-marked for easier identification and traceability. We also have the most stable clamping geometry in the market, resulting in less deviation when processing, smoother surfaces, less manual rework, and less tool/spindle wear.
Phil Brisebois on his experience with Elos pre-milled blanks:
A trusted provider, Elos Medtech delivers the flexibility and control you demand—and the predictable outcomes your lab or clinic relies on.