Panthera D-SAD Classic Oral Appliance Now Eligible for Medicare Reimbursement

Panthera Dental has received notification from the Pricing, Data Analysis and Coding (PDAC) contractor, following their request for a coding decision for the Panthera D-SAD Classic oral appliance. PDAC, following a formal review and assessment, has classified the HCPCS code (Healthcare Common Procedure Coding System) E0486 to be used when submitting claims for Medicare billing and other insurers who require PDAC verification following CMS (Centers for Medicare-Medicaid Services) policy.

panthera d-sad oral appliance

The Panthera Classic device is 3D printed and made from 100% medical-grade biocompatible polyamide 12 nylon. The versatility of medical-grade nylon removes traditional limitations in design, allowing for thinness, thickness, rigidity, or flexibility. Its pull/traction mandibular advancement mechanism is aligned with the occlusal plane, which has been shown to exert less force on the TMJ than an oblique push/compression design, thereby reducing the risk of patients developing TMJ disorders during treatment.1

Panthera Dental is leading the dental-sleep industry in manufacturing principles utilizing 4.0 technology that incorporates robotics, AI and laser sintering. The resourcefulness of nylon enables it to take any shape allowing the Panthera Classic to boast over 350 customization options. The turn-around time to deliver the Panthera Classic anywhere within the US is 8 days which means patients could be starting treatment sooner.

The therapeutic benefits for Medicare and Non-Medicare patients will be significant. The high degree of precision in the CAD/CAM production process means that Panthera Classic appliances are perfectly matched to the dental records provided. The fit goes beyond millimeters in fitting a patient’s anatomy, up to the micron ranges of fit. This often means a drop in fit, less chair time, and increased patient comfort.

The high durability of polyamide 12 nylon, making it virtually indestructible, combined with the latest in manufacturing 4.0 precision technologies, allowed for the company’s recent decision to issue a unique new ‘360 Warranty’. Not only does it offer a free remake for any appliance that breaks during normal use within 36 months, but Panthera Dental will also replace any appliance free of charge during the first 60 days, no questions asked. This is expected to give doctors and their Medicare patients unprecedented peace of mind when starting therapy.

“We are delighted that US practitioners can now offer our oral appliance therapy under Medicare,” said Gabriel Robichaud, CEO and Co-Founder of Panthera Dental. “It’s a milestone, not just for Panthera Dental, but more importantly for Medicare patients who can now receive a treatment that is truly personalized in a way that can only be achieved by Industry 4.0 manufacturing.” He continued “Our aim has always been to improve provider’s experience with oral appliances and to put our leading technology and in-house dental expertise to work to build efficiencies within their practices. We look forward to helping them treat even more patients in the future.”

Panthera Dental’s Digital Sleep Apnea Devices (D-SADs), the Panthera Classic and Panthera X3, have FDA 510(k) clearance for snoring and obstructive sleep apnea, bear the CE mark, and comply with the Canadian Medical Devices Regulations.


1. Cheze L. Impact on temporomandibular joint of two mandibular advancement device designs. ITBM-RBM. 27(5–6):233–7. 2006

Source: Panthera Dental

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