Brite Impressions

GEL CONTRACT FILING

BRITE IMPRESSIONS offers high-quality tooth-whitening gels in carbamide peroxide and hydrogen peroxide formulas at a range of concentrations suitable for in-office and in-home use. Most are available in syringe and bulk packaging in mint, peach, strawberry, cherry, melon and other fruity- natural flavors. Our proven effective formulations offer significant advantages over other leading brands.

Bulk gels are available at 6%HP, 9%HP, 12% HP, 16% HP, 20% HP and 25% HP in 55 gallon-drum size (420 lbs).

Other popular formula strengths are 15% CP, 22% CP, 30% CP and 35% CP also available in bulk, sold in 42 lbs pail or 420 lbs drum, minimum order 2 pails or 2 drums each shipment. Remineralizing Gel is also available in bulk.

We are a Registered Establishment with FDA, our products are listed with FDA. We export our products to 80 countries.

Filling

Using automated processes, all types of products – including syringes, pen casings, bottles, tubes, bulk cartridges and unit-dose products – can be filled with any type of chemistry, including blends, to meet your needs.

Printing

Syringes, pen casings, retainer cases, mini lights, toothpaste tubes can be decorated to any specification. We offer 3-color printing capabilities, as well as pad printing, silk screening, foil stamping and ink-jet printing.

Packaging

We have the technology to package any products – either ours or our clients' – into kits of any configuration. We specialize in precision, medical-grade thermo-formed packaging and have the in-house tooling and prototyping to rapidly design and engineer packaging to fit any specification–including unit-dose packaging.

Quality Assurance

All products are manufactured and tested in accordance with applicable standards of the American Dental Association, Food and Drug Administration, International Organization for Standardization, and the European Medical Device Directive 93/42/EEC. Our laboratory-manufacturing facility is verified to ISO 13485 and particular requirements of ISO 9001 by a recognized CMDCAS Registrar and CE marks products accordingly.

OEM *FAQ's

Q. What is the minimum run of products you will manufacture?
A. The minimum order we will manufacture is 1000 ea Pre-filled or Pre-loaded Whitening Trays, Whitening Pens, Liquid Whiteners, Take-Home Kits with Mini LED Lights.

Q. Is there a manufacturing set-up fee in addition to the prices we have received?
A. No, the prices that you were given include all manufacturing setup fees.

Q. What costs are involved with getting my labels created?
A. We can design your label from start to finish at a cost of $65 per hour. For more information, please visit our graphics and packaging section. We can also get your labels printed. When the labels are printed, one of the charges that you will notice is a plate charge. This is a one-time fee, and one plate is needed for each color used. Each plate costs $65. This fee is subject to change, as we only charge you what we are charged by the printer. The only time you will ever need to pay for new plates is if you make any changes to label in between runs.

Q. I have artwork created, what format do you need?
A. Ideally, Adobe Illustrator (.ai) files are preferred, with all fonts outlined. However, we will also accept .pdf, .eps, and .tif files. When submitting these other formats, please be sure that resolution is set to 300 dpi or better. Anything lower than this, we cannot guarantee the quality of print.

Q. What are your certifications?
A. All of our products are manufactured in an FDA Registered, cGMP certified facility, ISO 9001:2008 certified.

Q. When you say your materials are USP grade, what does that mean?
A. The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured in the United States. The USP conducts verification programs for dietary supplement ingredients and products. These programs involve independent testing and review to verify ingredient and product integrity, purity, and potency for manufacturers who choose to participate. For more information, please visit their website at www.usp.org.

Q. I don't have any place to store all of these syringes, can you keep some of them and ship them to me when needed?
A. Of course we can. You can issue us a Blanket Purchase Order and we will keep components on hand to manufacture products for you as needed, contact Diane Vo for fees and additional information.