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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 5 of 12
DeviceModel / ReferenceRegistriesClassStatus
Exquisite Restoration Unit Dose Shade A4 (20 per Pack) 1
FDA UDI
Class IIActive
Impact Air 45® 407
FDA UDI
Class IActive
Vista 2.5mm Saliva Ejector 806011
FDA UDI
Class IActive
Vista SU6 (Sub-Gingival) General Scaling P5 Tip 401409
FDA UDI
Class IActive
Vista HC (hygiene) Periodontal P5 Tip 401103
FDA UDI
Class IActive
Vista SPR (Right Angle) Apical Surgery EMS Tip 502405
FDA UDI
Class IActive
Low Speed Saliva Ejector Valve/Head/Filter assembly 803003
FDA UDI
Class IActive
Vista Zirconia Primer 4ml Bottle 1
FDA UDI
Class IIActive
Standard instrument with serrated tip 302704
FDA UDI
Class IActive
Vista EDTA Bulk Syringe 503700
FDA UDI
UActive
Vista Regular Micro-Applicator Brush (Green) 320804
FDA UDI
Class IActive
CHX Plus 503650
FDA UDI
UActive
Vista SAD (Universal, Diamond) Apical Surgery P5 Tip 401626
FDA UDI
Class IActive
Vista-Green Caries Indicator Standard Kit 502750
FDA UDI
Class IIActive
Titan Flowable Composite- 6 Syringe A Variety Pack (Shades- A1, 2 A3, A3.5, A4) 90489
FDA UDI
Class IIActive
Vista 3cc w 30ga Probe Tip 316239
FDA UDI
Class IActive
Single Cavity Well 90375
FDA UDI
Class IUnknown
Impact Air 45® 401
FDA UDI
Class IActive
RE-GEN Flowable Composite Shade A1 1
FDA UDI
Class IIActive
Vista 22ga Pre Bent Tip 315423
FDA UDI
Class IActive
Exquisite Restoration Syringe Shade Incisal 1
FDA UDI
Class IIActive
Vista Quick-Stat Kit (40pk) 502800
FDA UDI
UActive
SI-OL Length (2.0") Stopko Precision Irrigator 315260
FDA UDI
Class IActive
Vista GE40 (40mm) Endodontic P5 Tip 401402
FDA UDI
Class IActive
Titan Flowable Composite Single Syringe Pack Shade A3.5 1
FDA UDI
Class IIActive
Titan Flowable Composite Single Syringe Pack Shade A3 1
FDA UDI
Class IIActive
Voyager 29ga 27mm Dual Side Port 315829
FDA UDI
Class IActive
Vista Short NiTi Needle Tips 405107
FDA UDI
Class IActive
Best Etch 502235
FDA UDI
Class IIActive
Anchor 5ml Syringe Shade White Opaque 1
FDA UDI
Class IIActive
PS System - Chlor-Xtra Plus Bag (100mL) 803801-16
FDA UDI
UActive
Vista 16ga Bendable Tips 315116
FDA UDI
Class IActive
Vista CT4 (Thin Condensation) Apical Surgery P5 Tip 401407
FDA UDI
Class IActive
Vista Regular Universal Brush Tip 302002
FDA UDI
Class IActive
Liquid Dam Refill Kit 316051
FDA UDI
Class IActive
Anchor 25ml Cartridge Refill Kit Shade A2 1
FDA UDI
Class IIActive
Exacta- Flo Brush Tip 321650
FDA UDI
Class IActive
Seamfree Kit - Wetting Resin (3ml Bottle) 1
FDA UDI
Class IIActive
VistaCORE 5ml Syringe Shade White Opaque 1
FDA UDI
Class IIActive
White Opaque REGEN Flowable Composite 4pk of Syringes 90654
FDA UDI
Class IIActive
Piezo Pilot Ultrasonic Scaler 402716
FDA UDI
Class IIUnknown
RE-GEN Pit & Fissure Sealant 1
FDA UDI
Class IIActive
Vista #7 Clear Impression Tray 310007
FDA UDI
Class IActive
Vista PTU (Thin) Periodontal EMS Tip 502104
FDA UDI
Class IActive
Vista 25ga 1/2" Bendable Tips 315225
FDA UDI
Class IActive
Vista Sol-U-Flo- 500/Bag 312205
FDA UDI
Class IActive
Vista 1.0mm Endodontic Aspirator 804010
FDA UDI
Class IActive
25 green applicators in a tic tac box 90724
FDA UDI
Class IUnknown
Exquisite Restoration Unit Dose Shade A2 (20 per Pack) 1
FDA UDI
Class IIActive
Vista 3cc Syringe w/ 30ga Irrigating Tips 316139
FDA UDI
Class IActive

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