Solvay to launch dental care product line

Picture: Solvay

Solvay is entering into medical devices building on its world-leading portfolio of high-performance polymers with a new dental care business line. “Solvay Dental 360™” spans from an innovative material to replace metal in removable partial denture frames, to enabling a digital workflow that accelerates the work of dental laboratories and dentists.

Removable partial denture (RPD) frames replace missing teeth and are typically made of metal. Under Solvay Dental 360™, Solvay’s new high-performance material allows for metal-free, biocompatible, more comfortable, natural-looking RPD frames which are over 60% lighter than a metal frame.

Solvay uses its new Ultaire™ AKP (aryl ketone polymer) material to make its Dentivera™ milling disc. From this device, trained and qualified dental lab technicians use software tailored to this material to design and mill the RPD frame. This enhances speed and efficiency as fewer manufacturing steps are needed compared to the metal frame.

“Solvay’s entrepreneurial initiative to launch into medical devices is driven by our innovation power as a world leader in metal-replacing materials and their proven track record in healthcare,”said Jean-Pierre Clamadieu, CEO of Solvay.

“Solvay proudly starts off in dental care devices with a unique full-circle offering that increases the comfort of patients and efficiency for dentists and lab technicians,”said Shawn Shorrock, Global Director Solvay Dental 360™.

Solvay’s unrivalled portfolio of high-performance polymers cover over 35 brands in more than 1,500 formulations. In healthcare, they are used in orthopedic, cardiovascular, renal and other markets.

The Dentivera™ milling disc is approved by the EU and U.S. health regulators. The launch of Solvay Dental 360™ takes place at the 2017 International Dental Show (IDS) in Cologne, Germany.

Source: Solvay

Denttio warned by FDA for violating MDR procedures

FDA issued warning letter to Denttio Inc, in which FDA cited 12 violations to regulations. These regulations include but not limited to

1.    Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).
2.    Failure to establish procedures for corrective and preventive action as required by 21 CFR 820.100(a).
3.    Failure to establish a design history file as required by 21 CFR 820.30(j).
4.    Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g).
5.    Failure to maintain device master records as required by 21 CFR 820.181.
6.    Failure to establish procedures for finished device and incoming product acceptance as required by 21 CFR 820.80.
7.    Failure to establish Device History Record procedures as required by 21 CFR 820.184.
8.    Failure to adequately establish procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a).
9.    Failure of management with executive responsibility to review the suitability and effectiveness of the quality system as required by 21 CFR 820.20(c).
10.    Failure to perform quality audits as required by 21 CFR 820.22.
11.    Failure to adequately establish procedures for training and identify training needs as required by 21 CFR 820.25(b).
12.    Failure to establish document control procedures as required by 21 CFR 820.40 (a).
The warning letter is available on FDA website.