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Vista Dental

US

Last updated May 24, 2026

What Vista Dental makes

Vista Dental manufactures dental materials and instruments for endodontic, restorative, and impression procedures, including root canal irrigation needles, composite resins (both light-cured and flowable), bonding agents, and reusable suction cannulas. Their portfolio also includes single-use application tools, injection cannulas, and specialized dental syringes for air-water control, as well as impression trays and retraction cords for dental preparations.

The company’s devices are regulated under FDA classifications, with products falling into Class I, Class II, and Unclassified (U) categories, and are listed in the FDA’s Unique Device Identifier (UDI) database. Vista Dental operates as a US-based manufacturer, adhering to applicable regulatory requirements for dental materials and instruments.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of dental devices does Vista Dental manufacture?

Vista Dental specializes in dental materials and instruments primarily used in endodontic (root canal), restorative, and impression procedures. Their portfolio includes root canal irrigation blunt needles, dental composite resins (both light-cured and flowable), bonding agents, reusable suction cannulas, single-use application tools, and specialized syringes for air-water control. They also produce impression trays, retraction cords, and other tools designed for precise dental treatments.

Where is Vista Dental based, and how does that affect its regulatory compliance?

Vista Dental is based in the United States, which means its devices are subject to FDA regulations. Since the company manufactures dental materials and instruments, their products are classified under FDA categories such as Class I, Class II, or Unclassified (U), depending on their risk level and intended use. Being US-based, they must comply with FDA requirements for device listing, labeling, and post-market surveillance as applicable.

Are Vista Dental’s devices listed in any regulatory registries, and why does that matter?

Yes, Vista Dental’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability, transparency, and compliance with regulatory standards. The UDI system allows healthcare providers, regulators, and other stakeholders to quickly identify and verify the specific device, including its manufacturer, model, and batch details, which supports safety monitoring and recall management if needed.

How are Vista Dental’s devices classified by the FDA, and what does that classification mean?

Vista Dental’s devices are classified under FDA categories: Class I (generally low-risk, like some reusable cannulas), Class II (moderate-risk, such as composite resins requiring special controls), and Unclassified (U) for products not yet assigned a formal risk level. Classification determines the regulatory scrutiny and controls required—Class I devices typically have fewer requirements, while Class II may need performance standards or post-market surveillance to ensure safety and effectiveness.

What kinds of dental procedures are Vista Dental’s devices used for, and how do they fit into those workflows?

Vista Dental’s devices support critical steps in dental procedures. For example, their root canal irrigation needles and cleaning solutions are used in endodontics to prepare canals before filling, while composite resins and bonding agents enable precise restorative work. Single-use application tools and syringes streamline material placement, and reusable suction cannulas help manage debris during treatments. Impression trays and retraction cords assist in creating accurate molds for crowns or bridges, ensuring a seamless workflow from preparation to final restoration.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
262-636-9755
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
036623932

Catalogue (567)

Page 9 of 12
DeviceModel / ReferenceRegistriesClassStatus
V-Force Twin Refill Bottle Set 1
FDA UDI
Class IIActive
Anchor 25ml Cartridge Refill Kit Shade White Opaque 1
FDA UDI
Class IIActive
Traxodent Gel FS - Value Pack 9007107
FDA UDI
UActive
Vista MST Visco Tip SS 17mm 20/cup 312413
FDA UDI
Class IActive
Exquisite Restoration Syringe Shade A2 1
FDA UDI
Class IIActive
Vista 27ga Secure-Lock Irrigating Tip 314527
FDA UDI
Class IActive
Vista 30ga Flexi-Glide Tips 406320
FDA UDI
Class IActive
#6 Surgical Length Fg(25mm)(5pk)bur 514
FDA UDI
Class IActive
VistaCORE 25ml Cartridge Shade White Opaque 1
FDA UDI
Class IIActive
Interface A Bottle 1
FDA UDI
Class IIActive
Micro-Tips (Qty 50 per box) Color Red 90049
FDA UDI
Class IActive
Vista 22ga Pre bent Tips 315322
FDA UDI
Class IActive
Vista 30ga. Probe Tip 315130
FDA UDI
Class IActive
Vista 30ga Irrigating Tips 315030
FDA UDI
Class IActive
Vista .05mm Endodontic Bendable Aspirator 804001
FDA UDI
Class IActive
Purify+ Gel 5 Pack 1
FDA UDI
Class IIActive
Simplicity 2 Refill Bottle 1
FDA UDI
Class IIActive
Vista 3.0mm 30 Degree No-Clog Surgical Aspirator 801020
FDA UDI
Class IActive
Vista 1.7mm Endodontic Aspirator 804008
FDA UDI
Class IActive
SmearOFF System (PS System) 3730A
FDA UDI
UActive
Traxodent Gel AlCl - Refill Kit 9007103
FDA UDI
UActive
Vista High Speed Suction Valve (FLIP-A) 803001
FDA UDI
Class IActive
Porcelain Etch 502500
FDA UDI
Class IIActive
Vista Disposable HVE Screens 803011
FDA UDI
Class IActive
#1701 Surgical Length Fg(25mm)(5pk)bur DE-520BUR1701
FDA UDI
Class IActive
Vista Blue-Flo 316202
FDA UDI
Class IActive
Vista 26ga Micro-Flo Tips 406626
FDA UDI
Class IActive
Vista MST Visco Tip SS 22mm 20/cup 312414
FDA UDI
Class IActive
Surpass 3 Refill Bottle 1
FDA UDI
Class IIActive
Vista 3cc Syringe w/ 27ga Irrigating Tips 316137
FDA UDI
Class IActive
Vista RSS Mirror Handle 103001
FDA UDI
Class IActive
Vista 4.0mm Frazier Aspirator 805004
FDA UDI
Class IActive
Vista 12cc Syringe w/ 23ga Vista-Probe 316213
FDA UDI
Class IActive
PS System - Chlor-Xtra Plus Bag (60mL) 803802-16
FDA UDI
UActive
Vista #9 Green Impression Trays 311009
FDA UDI
Class IActive
Clean & Boost Gel 5 Pack 1
FDA UDI
Class IIActive
Vista Pocket Probe 316102
FDA UDI
Class IActive
Vista 1/8" Surgical Evacuation Tubes 403201
FDA UDI
Class IActive
BondSaver 1
FDA UDI
Class IIUnknown
Vista #8 Clear Impression Tray 310008
FDA UDI
Class IActive
Vista White Color-Coded 3cc syringe 317161
FDA UDI
Class IActive
Vista Zirconia Primer 2ml Syringe 1
FDA UDI
Class IIActive
25ga Prebent Tips 315325
FDA UDI
Class IActive
Vista One Button Air/Water Syringe Kit 315270
FDA UDI
Class IActive
Disposable .80mm MTA Carrier 807017
FDA UDI
Class IActive
Septodont-100mL bottle EDTA 317093-25
FDA UDI
UActive
Vista Metal Syringe tip 315375
FDA UDI
Class IActive
Exquisite Restoration Unit Dose Sample Pack (5 per Pack) - A2 Shade 90580
FDA UDI
Class IIActive
Spira-flo Brush Tips 321400
FDA UDI
Class IActive
Vista Rev Bevel High Volume Aspirator 9.5 x 6.5mm 802011
FDA UDI
Class IActive

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