Firm obtains FDA 510(k) clearances with assistance from Emergo Group
Online PR News – 28-September-2011 – – Neo Dental International, Inc., a Federal Way, Wash.-based marketer and distributor of dental products and devices on behalf of its parent firm Neo Dental Chemical Products Co., LTD. in Tokyo, has been cleared by the US Food and Drug Administration to market its Cavios® Cavity Liner product as well as its Evadyne® Temporary Resin product in the United States.
The Cavios product is a compound applied to the interior of prepared tooth cavities in order to protect tooth pulp prior to inserting filling materials. Evadyne is a temporary sealant used in cavity treatment procedures. Both products are applied via syringe. The firm already markets Cavios and Evadyne in the European Union.
Neo Dental obtained FDA 510(k) clearance for Cavios and Evadyne with assistance from medical device consulting firm Emergo Group. According to Neo Dental International Vice President, Treasurer and International Sales Manager Nobuki Ishikawa, the firm required consulting support for its FDA review process due to the regulator’s complex requirements.
“We had to use a consulting support group since it was not possible for us to give a direct submission to the FDA due to their many complex requirements,” Ishikawa explains.
Emergo Group already serves as Neo Dental’s Authorized Representative in Europe, so the manufacturer decided to extend its partnership with the consultancy to the US market. The firm had begun its FDA 510(k) submission effort with another outside firm several years ago, and after several delays decided to engage Emergo Group.
“Emergo Group helped us finalize the FDA 510(k) Premarket Notification application, so we could send necessary corrections to the FDA for final approval,” says Ishikawa, explaining that following submission of the paperwork, the final clearance process took about three months.
“Neo Dental experienced significant delays as the company started its 510(k) process,” explains Robert Seiple, Senior Consultant for Emergo Group. “We were pleased to be able to help them get Cavios and Evadyne to market in the US as quickly as possible.”
About Neo Dental International
Neo Dental International handles sales, marketing and distribution of dental products manufactured by its parent company, Tokyo-based Neo Dental Chemical Products. More information at Neo Dental's website.
About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical studies, in-country representation, reimbursement and distributor search consulting.
Neo Dental International, Inc.