Tag Archives: Dentures

Digital Full Dentures In 2 Appointments!

For further information, contact Udell Dental Laboratory
952-926-9266 or call toll free at 800-248-9943.

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It is now possible for patients to get full dentures in 2 appointments instead of 5 or more. The AvaDent Digital Denture System requires training in a new technique for taking impressions, so that all information is recorded by the doctor, and sent with the impressions and prescription. The impression technique and 3D design process allow the exact replication of the patient’s natural rugae, and the designer can precisely control the thickness of the denture for a more natural feel.

The dentures are milled from pre-shrunk disks of acrylic, so there is no shrinkage as with traditional dentures. The fit is precise on the first try. The high density acrylic disks are uniformly produced in a controlled process so the “monomer taste” of the newly-mixed acrylic denture material is reduced.

With the AvaDent process, partial dentures and implant-secured dentures can also be milled from your impressions.

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Digital dentures are close to becoming a reality.
For more information contact Udell Dental Laboratory
952-926-9266 or 800-248-9943

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New Federal 2.3% Medical Device Excise Tax

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Considerations for U.S. Dentists and U.S. Dental Laboratories in Light of Increased Regulation

The new 2.3% Medical Device Tax will have certain beneficial effects on the dental industry both in the U.S. and abroad.

Domestically, it will reinforce the requirement of using FDA registered materials in medical devices, by requiring the foreign manufacturer and importer to provide documented proof of material composition and provenance. It is also an important next step toward global quality regulation of medical devices, already well established in many markets, through ISO quality standards and U.S. FDA regulation.

The low prices offered by foreign labs with lower operating costs are challenging the U.S. dental lab industry. With the new Medical Device Tax, the increased cost of regulating and importing medical products may help to balance the playing field. U.S. dentists may re-evaluate the benefits of choosing a full-service domestic dental laboratory, and using highly skilled U.S. technicians.

Defining the “Taxable Medical Device” under the 2.3% tax law

The IRS looked to the FDA for definition of a “taxable medical device”, and the key is FDA registration. All manufacturers, producers, and importers of medical devices must register with the FDA and submit a list of the medical devices that they manufacture, produce, or import. All “listed” devices are subject to the new 2.3% tax.

All imported dental devices are required to be listed. Each type of imported restoration receives a product code, and is taxable under the law.

Whoever imports as the initial owner of the device, whether it is a dental laboratory or a dentist, is responsible for paying the tax.

Dental laboratories are generally exempt from registering with the FDA, unless they import devices from foreign labs. With the exception of sleep apnea devices and snore guards, most domestically made crowns, bridges, dentures, veneers and retainers will not be subject to the tax. However, many materials and components used by dental labs will be taxable as medical devices.

The Dentist and Laboratory Relationship

In all countries, dentists benefit from working with full service local laboratories. They often know the technicians by name, the level of their skill, and can expect consistent quality work. They also know the quality of the materials used, and can rely on clear communication for difficult combination cases.

In the U.S. particularly, domestic laboratories are required to have an established quality management system in place to provide the required material and process control, and confidential patient history with full traceability for every case. U.S. labs are also subject to audit at any time to assure regulatory compliance.

Dental restorations are patient-specific medical prosthetic devices. With such a direct patient interface, dental restorations should not be marketed as a commodity. Until such time that global quality regulation is practicable, there will be measureable benefits for the dentist who works with the local dental laboratory.