Tag Archives: partial denture

Valplast Flexible Partials – 3D digital modeling, manufacturing and repair at Udell Dental Laboratory

Today’s Top Dentists prescribe Valplast as the preferred material for flexible partial dentures. Still an innovative product after decades of clinical use, Valplast is an excellent esthetic solution for the replacement of missing teeth where cost or physiological factors preclude fixed restorations. Valplast is biocompatible for patients with allergies to acrylics, and the level of comfort is superior to metal frameworks or other resin-based partials.

Udell Dental Laboratory is an Advanced Certified Valplast laboratory.
We manufacture Valplast partials using 3D modeling and manufacturing technology. Digital modeling allows for fast and accurate control of material thickness, clasp placement, and detailing, vastly improving production time and ensuring consistent product quality.

Udell Dental Laboratory is one of the few laboratories that routinely provide Valplast alterations and repair for patients with changes in oral anatomy or damaged partials. Valplast can be repaired and re-lined using recommended techniques from the manufacturer. Other traditional repair processes will not work on Valplast partials due to differences in materials and techniques.

For More Information on Valplast call Udell Dental Laboratory!
800-248-9943
http://www.udelldental.com/partial-dentures.htm

Advertisements

New Federal 2.3% Medical Device Excise Tax

Import_Excise_Tax

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.

New Federal Medical Device Excise Tax will not apply to vast majority of products made by U.S. Domestic Dental Laboratories

US_ExciseTax_Small

Read more at http://www.nadl.org/pdfs/MDT-Press%20Release%20Dft%2010-19-12.pdf