Dentsply Caulk

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Web: http://www.caulk.com
E-Mail:
Address: 38 W. Clarke Avenue, Milford, Delaware 19963, USA
Phone: +1-(800)-532-2855 | Fax: +1-(800)-788-4110 | Map/Directions >>

Profile: Dentsply Caulk offers dental products. Our product categories are alloys & accessories, bone grafting materials, burs, cements & liners, impression materials, irrigation probes, and x-ray products. Our XP Bond adhesive has excellent bond strength to both enamel & dentin. It has proven Penta™ and nano-technology chemistry & a new tertiary-butanol solvent. Our CeramX™ restorative is designed to meet the needs of both dentists and patients. It uses unique nano-ceramic technology and offers non-sticky handling & excellent durability. The two simple shading systems mimic natural tooth color, allowing dentists to offer patients outstanding esthetics with a minimal number of shades.

The company was founded in 1877, has revenues of USD 50-100 Million, has ~9400 employees and is ISO 9000, ISO 9001, CE certified. NASDAQ:XRAY (SEC Filings)

FDA Registration Number: 2515379

25 Products/Services (Click for related suppliers)

• Adult Tongue Depressor (FDA Code: FMA / 880.6230)

A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Breathing Mouthpiece (FDA Code: BYP / 868.5620)

A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

• Dental Protector (FDA Code: BRW / 868.5820)

A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.

• Dye Solution Stain (FDA Code: LEE / 864.1850)

Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 876.1500)

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Flexible Padded Abdominal Retractor

• General & Plastic Surgery Surgical Burr (FDA Code: GFF / 878.4820)

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• General Medical Supplies

• General Surgery Supplies

• Infant Tongue Depressor (FDA Code: FMA / 880.6230)

• Junior Tongue Depressor (FDA Code: FMA / 880.6230)

• 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 Device, Sterilant (FDA Code: MED / 880.6885)

A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

• Medical Instrument Ultrasonic Cleaner (FDA Code: FLG / 880.6150)

An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.

• Non-Surgical Tongue Depressor (FDA Code: FMA / 880.6230)

• Paraffin Dispenser (FDA Code: IDW / 864.3010)

Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800)

A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

• Radiographic Anthropomorphic Phantom (FDA Code: IXG / 892.1950)

A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.

• Radiographic Film Illuminator (FDA Code: IXC / 892.1890)

A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

• Radiological Digital Image Storage Device (FDA Code: LMB / 892.2010)

A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

• Radiological Image Processing System (FDA Code: LLZ / 892.2050)

A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Steam Sterilizers (FDA Code: FLE / 880.6880)

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

• Surgical Masks (FDA Code: FXX / 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.

• Tongue Depressors (FDA Code: FMA / 880.6230)

• X-Ray Accessories, Leaded Aprons (FDA Code: EAJ / 892.6500)

A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.