Panthera Classic (D-SAD™)

This appliance can only be sold by Great Lakes to doctors in the United States.

Special Notes

This appliance is PDAC Verified for Medicare Reimbursement - E0486

To view prices, please create an account. The photograph shows our standard design. We can customize many of our appliances for your patient's specific needs - please see our auxiliaries and color chart (not applicable for nylon appliances).

LAB APPLIANCE This product is a custom lab appliance. Please choose the "Send us a Case" option on the product page or top menu bar.
Item Number
IDSAD
Rating:
87 % of 100

One of the smallest, lightest and most durable sleep appliances on the market.

The Panthera Classic (Digital Sleep Apnea Device), is an FDA approved, effective treatment for snoring and obstructive sleep apnea. When worn at night, the Panthera Classic positions the lower jaw in a forward position, relieving snoring and mild to moderate sleep apnea conditions.

The fully CAD/CAM Panthera Classic is custom designed on a computer from optically scanned information, then 3D printed using the latest technology and materials. It is made from biocompatible polyamide medical grade nylon.

  • It does not contain BPA, phthalate or resin.

Connecting rods are made of the same biocompatible polymer as the device. Unique rod connection points ensure that the device will not disengage during sleep, elongate or distort.

  • 20 rod pairs (10 per side) included with each appliance in .05mm increments.

The Panthera Classic (D-SAD™) Appliance is PDAC (Pricing, Data Analysis and Coding Contractor) verified for Medicare reimbursement. The Code is E0486. FDA Reference #K955822.

Please see the Downloads tab for additional doctor instructions.

More Information
GLO Exclusive No
Turnaround Time 18 Business days
Medicare Accepted No
Indications Snoring/Mild to Moderate OSA
Contraindications Generalized Periodontitis, Insufficient Number of Teeth, Severe Osteoarthritis, TMJ and Chronic Pain, Under 18 Years of Age
Removable Yes
Banded No
Bite Required Protrusive
Material Type Biocompatible Polyamide Medical Grade Nylon
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Mail Traditional Models

Step 1 - Download Prescription

Panthera Classic (D-SAD™) Rx

Step 2 - Print a Shipping Label

Step 3 - Mail it in!

Canadian and International Customers

Ship to:

Great Lakes Dental Technologies
PO BOX 5111
Tonawanda NY 14150-5111
USA


Upload Digital Models

Option 1

Select your scanner to view easy instructions on how to submit a digital model.

Great Lakes also supports DDX, Medit, and Planmeca. If you need assistance, please contact us.

Option 2

Upload your digital models to the Great Lakes Digital Portal. It's a simple and secure way that accepts STL files from any scanner. Click here for instructions.

How it works

Instructions (12 video playlist)

Adjustments Using Heat

Appliance Specific

Intraoral scans or models -
  • Upper and Lower with palate
  • 4-5mm extended beyond gingival margins
  • See Rx for bite requirements

General Requirements

Impressions:

  • Accurate impressions with any type of impression material are acceptable
  • Impressions must adequately reflect all relevant anatomy
  • Impression material must not be separating from the impression tray
  • Consider pouring your models right away if your impressions are moisture, temperature, or time sensitive
  • Impressions sensitive to moisture content should be wrapped in a damp paper towel and placed in a sealed plastic bag if models are not poured immediately
  • Only metal impression trays and those with VPS impression material will be returned
  • The nature of impression materials currently on the market may contribute to common model problems encountered in the laboratory. Have you encountered porosity (bubbles, voids) or poor surface quality? Plaster or stone mixes are water based and they interact with impression surfaces in a water-like manner. Liquids placed on solid surfaces will be either attracted to, or repelled from that surface in varying degrees. Please be aware when selecting impression material if it is hydrophilic or hydrophobic.

Hydrophilic: is attracted to, or can be wetted by water.
Hydrophobic: is when liquid is repelled or fails to bond with liquids.
Vinyl poly siloxane (VPS) options can be hydrophilic or hydrophobic. Alginate is hydrophilic.

  • There are advantages and disadvantages to these impression options but there are products on the market to help reduce the disadvantages. Surfactants and debubblizer sprays can be used to lower surface tension between surfaces making the impression material more hydrophilic and assure a better impression result.
  • Great Lakes carries ACU-flow™ a VPS impression material which is hydrophilic and requires NO surfactant spray for surface tension reduction, eliminating bubble formation. Surfactants must be used properly and excess surfactant should not be allowed to pool in the cusp tips. This can cause loose, sandy-like cusp tips. Excess surfactant needs to be blown out leaving a wet look only before pouring. 

Learn how to take a reliable impression

Models:

  • Plaster or stone models are acceptable. Generally, the durability of stone is preferred.
  • Models should be reasonably trimmed, yet sufficiently thick for strength considerations.
  • No horseshoe-shaped models; Models should have a base of at least 7mm in the thinnest area.
  • Bases will be added as necessary (for an additional fee) to models without bases or those lacking adequate base thickness or strength.
  • Please indicate if your model must be duplicated as work models may get damaged during the appliance fabrication process.

Bite Records:

  • Please package bite registrations carefully.
  • Bite records must not be left between models for shipment to the lab.
  • Dedicated packaging should be considered for brittle materials such as Delar wax.
  • Please identify the nature and the intent of each bite record, if more than one is being supplied.
  • Please consider mounting the maxillary model, before sending it to the lab, for those cases requiring mounting. Sending items such as facebows, bite forks, and mounting jigs through the mail often results in unreliable mountings.

Articulators:

We use the following articulators and their accessories in our laboratory:

  • SAM® 1, SAM® 2, SAM® 3 
  • Denar®
  • Panadent
  • Whip Mix
  • Hanau™
  • Stratos 200
  • Artex®
  • Kavo

Care Instructions

Clean with approved dental cleaner provided with appliance.

Wear Times

Nighttime

Appliance Warranty

Panthera Dental warrants all sleep devices supplied to be free from defects in material and workmanship for a period of 36 months from the date of shipping to the device provider.

For the first 60 days from the shipping date to the device provider:

  • Panthera Dental will replace the device free of charge, no questions asked*

For 36 months from the shipping date to the device provider:

  • Panthera Dental will replace any device free of charge in case of in-mouth material breakage that is not the result of any moditications that could alter the normal use of the appliance
  • For any issue other than in-mouth breakage, and if no new models or impressions are required to remake the case, Panther Dental will replace any device at a 50% charge no questions asked*
  • If new models or impressions are required, the warranty is void and the new device will be invoiced at full cost.

Panthera Dental sleep devices are medical devices regulated by the U.S. FDA, Canadian Medical Devices Regulations SOR/98-282 and EU Directives 2007/47/CE. Therefore, all devices replaced must be returned before or after replacement.

* Not applicable for lost appliances.

Panthera Dental's warranty is a manufacturer warranty applicable to its sleep devices only. Clinical costs are not covered.