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Medical Device, News, Toxicology | June 4, 2021

CLIENT TESTIMONIAL – SPLINTEK, INC.

by PBL

Pacific BioLabs works hard to be The Service Leader in Life Science Testing, and nothing makes us more proud then receiving commendations from our clients.

Kyle Schwenker, Chemist at Splintek, Inc. had this to say:

“Our company manufactures dental guards that protect the teeth during bruxism or nighttime teeth grinding. For our intent to market a new dental guard, we must submit a premarket notification, referred to as a 510(k) to the Food and Drug Administration (FDA). Within the 510(k), one of the requirements for dental guards is to conduct biocompatibility testing on them. For the past four years, we have requested biocompatibility testing from Pacific BioLabs (PBL). We originally chose PBL to perform our testing based on their FDA and International Organization for Standardization (ISO) certifications; as well as their competitive pricing compared to other certified testing facilities.

Since then, we are still impressed with their certifications and pricing; but additionally, they always provide our testing results on time and are always eager to answer any questions we have. Not to mention, they are only a phone call away to discuss new devices and testing procedures; and their employees do a great job at replying to requests in a timely manner. PBL has conducted Cytotoxicity (MEM Elution), Sensitization (ISO Maximization Test for Delayed-Type Hypersensitivity), and Irritation (ISO Intracutaneous Reactivity Test) tests for us on four dental guards. Our testing results are always reported in an organized manner that is easily understandable and consistent. It is for all of these reasons that we will be requesting biocompatibility testing from PBL again on two additional guards in the immediate future. Needless to say, we are very pleased with our experience with PBL and will continue collaborating with them for our testing needs in the years to come.”