Profile: Pac-Dent Intl., Inc. specializes in the design, manufacture and wholesale of disposable dental products & small dental equipment. Our products include Briter whitening pen + Remi™ desensitizing paste combo, iBrite™ V4 LED tabletop teeth whitening light, dual-arch fluoride trays, disposable brush cups, instrument trays and X-ray accessories. Our dual-arch fluoride trays are color coded, foam trays designed to offer a naturally contoured fit and comfort for fluoride treatments. Our disposable brush cups are used for orthodontic cleaning, polishing & removal of heavy stains, and are available in snap-on or latch type. We also provide various mixing bowls, suction adapters, non-woven sponges, endodontic rulers, heat sealers, dental hand instrument holders, plastic trays and disposable surgical masks.
FDA Registration Number: 2086043
24 Products/Services (Click for related suppliers)
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| • Cement Mixing Equipment (FDA Code: JDZ / 888.4210) A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027). |
| • Cotton Rolls |
| • Disposable Impression Syringes |
| • Face Shield |
| • Faceshields |
| • Full Face Shield |
| • Gallstone Scoop (FDA Code: FHL / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. |
| • General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 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. |
| • General Surgical Manual Instrument (FDA Code: MDM / 878.4800) |
| • Heat-Sealing Device (FDA Code: KSD / 864.9750) A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components. |
| • Liquid Medication Dispenser (FDA Code: KYX / 880.6430) A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication. |
| • Medical Devices, Disinfectant (FDA Code: LRJ / 880.6890) A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. |
| • Mouth Guard |
| • Needle Tips |
| • Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds. |
| • Non-Sterile Specimen Container (FDA Code: NNI / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing. |
| • Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use 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) |
| • Ophthalmic Eye Shield (FDA Code: HOY / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place. |
| • Ruler and Caliper (FDA Code: FTY / 878.4800) |
| • Surgical Dress (FDA Code: FYE / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. |
| • Surgical Instrument Tray (FDA Code: FSM / 878.4800) |
| • Trays |
| • X-Ray Detectable Gauze (FDA Code: GDY / 878.4450) Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements. |