Let's face it — FDA compliance doesn't exactly sound like a thrilling topic. But what if l told you there's finally a straightforward way [or your lab to mill custom abutments without drowning in paperwork?

If you've been in the dental lab world for any length of time, you've probably considered bringing custom abutment production in-house... only to be scared off by scary-sounding terms like "quality management systems," "validation processes," and those dreaded "regulatory requirements." I get it — who has time for all that when you're trying to run a laboratory?

Good news: there's now a solution that won't make your head spin — the DESS PNP (Plug-and-Play) Workflow.

Why Custom Abutments Matter (But Have Been Such a Pain)

We all know stock abutments have their place, but let's be honest — they can't deliver the kind of custom emergence profiles that create truly outstanding results. Your clients want perfect tissue management and aesthetics, and that requires custom solutions.

Until recently, your options were pretty limited:

1. Go all-in on implementing a massive Quality Management System (think binders upon binders of documentation, regular audits, and training headaches)
2. Outsource to the big milling centers, losing control and watching your profits shrink

Neither option felt great, right? That's exactly why the DESS PNP approach is such a difference maker in our labs.

The FDA Stuff (Made Simple, I Promise)

Before we dive into the solution, here's the regulatory situation in plain English:

The FDA categorizes dental implant parts based on how long they stay in someone's mouth:

• Class I Devices: The temporary visitors (scan bodies, analogs, etc.)
• Class II Devices: The permanent residents, including:
• Pre-made parts like MUAs
• Components designed to be modified (like titanium bases and premill blanks)

The FDA's big concern? Who's modifying those Class II parts and how they're doing it. This is where things traditionally get complicated for labs.

Two Paths to Compliance (One Much Easier Than the Other)

The Old Way: Full-Blown QMS Implementation

Traditionally, if you wanted to mill custom abutments in-house, you needed:

• A comprehensive quality management system (think corporate-level documentation)
• Those infamous three-ring binders filled with procedures and records
• Regular audits (as fun as they sound)
• Complete traceability of everything you do
• Specially trained staff who've been "validated"

Most of us took one look at this approach and said, "No thanks!" This is the path big milling centers like Atlantis have taken —and they have entire departments dedicated to compliance.

The Better Way: DESS PNP Workflow

Here's where DESS has changed the game. They've created what they call a "cookbook approach" to compliance. And who doesn't prefer following a simple recipe to creating an entire restaurant management system?

With the PNP workflow, you:

1. Follow a clear-cut process using equipment and materials DESS has already validated
2. Keep minimal documentation (mostly just tracking where parts go)
3. Skip the staff validation and ongoing audits

The real beauty here? DESS has already done the heavy lifting with the FDA. They've validated specific combinations of equipment, software, and materials so you don't have to. It's like having a compliance partner who's already mapped out the safest route through the regulatory maze.

The PNP Recipe: What You'll Need

Just like any good recipe, the PNP workflow requires specific ingredients that have been tested to work together. DESS continues adding to this list, but here's what's currently validated:

Scanning Equipment

• Intraoral scanners: 3Shape TRIOS, iTero, Medit (with more on the way)
• Lab scanners: 3Shape E series and 2000 series

Design Software

• 3Shape Dental System with Implant Studio
• exoCAD

CAM Software

• DentalCAM
• DentalCNC
• hyperDENT
• mBOX (for zirconia)

Milling Machines

• VHF mills
• Versamill
• Roland (for zirconia)
• Several others in the testing pipeline

Materials

• Various validated zirconia brands (Zirkonzahn, ArgenZ, Vita)
• DESS titanium premills
• Multi-link Hybrid cement from Ivoclar

Why You'll Love DESS Titanium Premills

At the heart of this workflow are the DESS titanium premills, which offer some serious advantages:

• Made from medical-grade titanium (the good stuff)
• Come with a sturdy holder that eliminates that annoying chatter during milling
• Allow milling super close to the interface (0.3mm), so you can truly customize
• Available with pre-milled angulated screw channels (because who wants screw access holes in the facial?)
• Compatible with tons of implant systems through DESS's extensive connection library

Getting Started: Easier Than You Think

Ready to jump in? The process is refreshingly simple:

1. Reach out to DESS or Zahn Dental
2. Register with the FDA as a pass-through entity (sounds scary, but DESS walks you through it)
3. Check if your current equipment is already on the validated list
4. Follow the workflow (their step-by-step guide makes this simple)
5. Keep basic tracking records

As DESS puts it on their website: "We've created a simplified and compliant process that doesn't require establishing a comprehensive quality system." 

Music to a lab owner's ears, right?

Why This Matters for Your Lab

Let's talk about the real benefits of adopting the DESS PNP Workflow:

Peace of Mind

No more lying awake at night wondering if you're on the right side of FDA regulations. Follow the recipe, and you're good to go.

Predictable Results

The validated combo of equipment, software, and materials means consistent, high-quality outcomes every time.

You're in Control

Bringing custom abutment production in-house means controlling your timeline, quality, and costs — no more waiting on outside milling centers or watching your margins disappear.

Stand Out from the Crowd

Being able to offer truly custom abutment solutions positions your lab as a comprehensive implant partner for your clients. That's a competitive edge.

DESS: Your Compliance Buddy

Perhaps the most refreshing part of all this? You don't have to figure it out alone. DESS has positioned themselves as your partner in this process. They've:

• Already done the hard work with the FDA
• Created easy-to-follow documentation
• Established support systems for labs implementing the workflow
• Continued expanding the list of validated components

As they say on their website: "We're not just a manufacturer; we're your compliance partner." And who couldn't use another ally when navigating regulatory waters?

The Bottom Line

The DESS PNP Workflow has transformed what was once a major headache into a manageable process for dental labs. By creating this simplified, FDA-compliant pathway, DESS has removed the biggest obstacles that have kept labs from offering these valuable services.

If you've been thinking about bringing custom abutment production in-house but have been intimidated by the regulatory side of things, the PNP workflow offers a practical solution that won't have you drowning in paperwork or compliance concerns.

With DESS as your partner, you can focus on what you do best — creating exceptional restorations — while they help handle the regulatory maze. Now that's a partnership worth having.

Ready to make custom abutment production a headache-free part of your lab services? Visit www.dess- usa.com/pnp/or give DESS a call to get the ball rolling.

Jimmy Stegall CDT 

A 43 dental industry veteran educator, author, & 2024 NADL Educator of the Year, has presented hundreds of  education & training events advancing digital dentistry in dental laboratories & practices across North America.