The AGGA Dental Device: What Patients Need to Know

What Is the AGGA?

The AGGA, or Anterior Growth Guidance Appliance, is a metal wire device fitted between a patient's upper teeth, invented by a Tennessee dentist and marketed to dentists and patients nationwide as a way to “remodel” and expand the jaw without surgery or traditional orthodontics. According to court records cited in national reporting, the device has been used on approximately 10,000 patients.

The device has been marketed with a wide range of claims over the years: that it could correct a misaligned bite, widen a narrow palate, improve breathing, and even help treat sleep apnea and TMJ (jaw joint) disorders — all without surgery, without braces, and in adults whose jawbones have long since finished growing. Those claims are central to why the device has drawn scrutiny from journalists, regulators, and patients' attorneys alike.

Importantly, the AGGA has never received FDA clearance or approval. Reporting on the device, along with the manufacturer's own securities filings, has confirmed that it is a non-FDA-cleared oral appliance — meaning it was never independently reviewed by federal regulators for safety or effectiveness before being marketed and used on thousands of patients.

The CBS News / KFF Health News Investigation

In March 2023, CBS News and KFF Health News (formerly Kaiser Health News, or KHN) published a joint investigation into the AGGA, based on interviews with roughly a dozen patients who said they were seriously harmed by the device, along with dental specialists who reviewed their cases and confirmed the injuries were consistent with the device's use. One patient featured prominently in the reporting alleged that instead of remodeling her jaw as promised, the device pushed her teeth forward through the bone that anchors their roots — a serious and often irreversible type of damage that can ultimately require tooth extraction and extensive reconstructive dental work.

Following the investigation, the FDA publicly announced it was evaluating safety concerns tied to the AGGA and a related device, the Anterior Remodeling Appliance (ARA). By April 2023, reporting indicated federal investigators had opened a criminal investigation into the device and how it had been marketed to dentists and patients. In the years since, the device has been rebranded under a new name, the Osseo-Restoration Appliance (ORA), though available reporting does not indicate the underlying design or the lack of FDA clearance has fundamentally changed.

The Inventor's Own Testimony

In sworn testimony given in late 2023 as part of the litigation against him, the device's inventor reportedly walked back a number of the original claims made about what the AGGA could treat, while in other statements continuing to defend the device's use for conditions like mild to moderate sleep apnea. That inconsistency — between how the device was marketed to dentists and patients for years, and what its own inventor was willing to say under oath — has become a central issue in the litigation that has followed, and is part of why plaintiffs' attorneys view these as strong cases.

What Patients Have Reported

Patients who received the AGGA, and in some cases a similarly-marketed device called the ALF (Advanced Lightwire Functional) appliance, have reported a range of complications, including:

• Teeth pushed forward through the bone that anchors their roots, rather than the jawbone itself being remodeled as promised
• Permanent tooth loosening, tooth loss, or the need for extraction
• Gum recession and exposed, sensitive tooth roots
• Nerve damage, in some reported cases
• Significant bite misalignment requiring extensive corrective treatment, sometimes including surgery
• Little to no improvement in the breathing, TMJ, or sleep apnea symptoms the device was marketed to treat

Because the AGGA was marketed to adult patients — whose jawbones have already fully developed — many dental specialists interviewed as part of the CBS/KFF investigation questioned whether the underlying premise of the device, that it could safely “regrow” or expand an adult jaw, was ever scientifically sound to begin with.

Why This Matters Legally

When a medical or dental device is marketed with claims that go beyond what mainstream research and the device's own regulatory status support — particularly a device that has never received FDA clearance — and when patients are not properly warned about the risks of what amounts to a largely unproven procedure, there may be grounds for a legal claim. These cases typically fall under defective drugs and devices litigation, and can involve claims against the device's manufacturer or marketer, and in some circumstances the treating dentist, depending on what they knew, what they were told by the manufacturer, and what they disclosed to their patient.

Because so many patients nationwide were fitted with the AGGA based on similar marketing claims, these cases are often litigated as part of a larger group of similarly situated patients, which can strengthen the evidence available in any individual case and help establish a consistent pattern of harm.

In Connecticut, product liability claims are generally subject to a three-year statute of limitations from the date the injury was discovered or reasonably should have been discovered, under Connecticut General Statutes § 52-577a. You can read more detail on how these deadlines work on our Connecticut personal injury statute of limitations page.

What to Do If You Have This Device

If you currently have an AGGA, ARA, ORA, or ALF appliance, or recently had one removed, a few steps can help protect both your health and any potential legal claim:

• Request a complete copy of your dental records, including any before-and-after imaging, treatment notes, and any consent forms you signed, from the dentist who provided the treatment.
• Consult with a dental specialist — ideally an orthodontist or oral surgeon not affiliated with the original treating provider — to evaluate the current condition of your teeth, gums, and jaw, and to get an independent opinion on any damage.
• Keep a written record of your symptoms and when they began, including any pain, tooth movement, bite changes, or breathing issues you've noticed since treatment began.
• Avoid having the device removed or replaced without first documenting its current condition and position, since that documentation can be important evidence in a future claim.
• Hold onto any marketing materials, consultation notes, or communications from your dentist describing what the device was supposed to do, since these can help establish what you were told and promised.

Similar Devices Facing Similar Scrutiny

The AGGA is not the only device of its kind to draw attention. The ALF (Advanced Lightwire Functional) appliance and the ARA (Anterior Remodeling Appliance) have been marketed with similar claims about non-surgical jaw remodeling, and have drawn similar concern from dental specialists and regulators. If you were treated with any of these devices, or a device marketed under a similar “jaw growth” or “airway expansion” premise, many of the same legal considerations discussed here may apply. It's worth having any of these treatments reviewed, even if the specific device you received isn't called an AGGA.

Common Questions From Patients

How do I know if I have a case? Generally, the strongest cases involve documented complications — tooth movement, bone loss, gum recession, or ongoing pain — that a dental specialist can connect to the device's use. A free case evaluation is the fastest way to find out.

Is it too late if I had the device removed years ago? Not necessarily. Connecticut's discovery-based statute of limitations for product liability claims means the clock generally starts when you discovered, or reasonably should have discovered, that the device caused your injury — not necessarily the date of treatment itself. It's worth having your specific timeline reviewed rather than assuming too much time has passed.

What if my dentist said the device was safe? Many dentists who used the AGGA relied on the manufacturer's own marketing and training materials, which is part of why these cases often focus on the manufacturer's conduct. Your dentist's good-faith reliance on those materials doesn't necessarily mean you don't have a claim — it's a question worth having evaluated directly.

If You Received AGGA Treatment

If you or a family member were treated with the AGGA — or a device marketed under a related name like ARA, ORA, or ALF — and experienced dental or jaw complications, it's worth having your case reviewed. You can learn more on our AGGA Dental Device Lawsuit page, or contact us for a free, no-obligation case evaluation.

A Note on Choosing the Right Attorney

Defective device cases like this one often involve a manufacturer, marketing entity, and treating providers spread across multiple states, along with a growing body of litigation nationwide. Choosing an attorney who understands how to coordinate with that broader litigation — rather than treating your case as an isolated dental malpractice matter — can make a meaningful difference in the outcome. Our firm has the resources and experience to evaluate your case within that larger context.

Jazlowiecki & Jazlowiecki LLC has represented clients in complex product liability and defective device cases for decades. We offer free case evaluations, and there's no fee unless we win.