Profile: Sunstar Butler, Inc. designs, manufactures and distributes oral health care products. Our product categories are toothbrushes, between teeth cleaning, interdental, pain management, operatory and dental kits. Some of our products are adult toothbrushes, specialty toothbrushes, flossers, floss threaders, orthodontic wax, desensitizing solution and oral rinse. Our Gum® Rotapower power toothbrush has a rotary head with oscillating soft bristle action for effective cleaning. Its longer bristles around its head edges penetrate between teeth and clean along the gumline. Our Gum® Crayola™ flossers improve oral hygiene by removing more plaque than brushing alone. It features easy-to-grip handle that improves control for small hands. Its narrow head fits comfortably inside small mouths.
The company has ~300 employees and is ISO 9000, CE certified.
FDA Registration Number: 1413787
5 Products/Services (Click for related suppliers)
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• General Disinfectants |
• General Medical Supplies |
• Hydrogel Wound and Burn Dressing (FDA Code: MGQ) |
• Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE / 878.4022) A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. |
• Operating Room Scrub Brush (FDA Code: GEC / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |