Companies / VistaApex Solutions

Medical device company profile

VistaApex Solutions

Dental device and materials group spanning endodontics, restorative care, periodontal products and small equipment.

Medical Device ManufacturerDental & Oral HealthEndodonticsRestorative DentistryCommercial-stage

Headquarters🇺🇸Racine, Wisconsin, United States

FoundedNot confirmed

Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.

EmployeesNot confirmed

Estimated revenueNot confirmed

Official websitevistaapexsolutions.com ↗

Company overview

VistaApex Solutions brings together dental brands including VistaApex, PerioProtect and PerioSciences. The group offers endodontic and restorative products, periodontal-care systems and small equipment, with clinician involvement informing product development.

The selected device scope includes PinkWave curing technology, Vista BC Putty and endodontic sealer solvent. FDA decisions for the latter products name Inter-Med, Inc. as applicant; those records are retained with their original legal identity rather than generalized to every group brand.

CEO Eric Shirley leads the Racine-based business. Its commercial model combines product development, clinician education and dealer channels. A manufacturer-published directory documents North American dealer relationships, while older Vista Dental irrigant recalls remain separately identified as historical events.

^{[47][48][49][50][54]}

Leadership

1 people

Eric ShirleyChief Executive Officer ^[54]

Products & regulatory status How does MedTechIndex get this information?

Summary

VistaApex combines cleared dental devices and materials under Vista/Inter-Med and Apex applicant names. The audit adds relevant dental authorization history while excluding unrelated Inter-Med neurological and urological devices. Current PinkWave, BC Putty and other selected products do not inherit every group or supplier clearance. ^{[47][12][7][49][1]}

The matched FDA history contains 2 distinct recall events: 1 open, 1 terminated. Z-2400-2026 (2026-05-27; open, classified): Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case… ^[42]

Regulatory snapshot How to read this snapshot

U.S. FDA

2
510(k) clearances: 0
De Novo grants: 0
PMA approvals: 0
Recall events

Latest recorded source review: 2026-10-20.

View 1 documented open recall event

Includes open events outside the mapped current portfolio; those events are excluded from the snapshot count.

Documented open FDA recall events
Recalled product / record	Initiated	Source
Advance Aluminum Chloride Gel Clear Hemostatic Gel KitZ-2400-2026	May 27, 2026	^[42]

Commercial portfolio snapshot

Documented commercial product families.

Dental curing light

PinkWave QuadWave Curing Light ↗

Multi-wavelength curing light offered through the VistaApex portfolio. ^[47]

Marketed · regulatory scope varies

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Endodontic material

Vista BC Putty ↗

Root repair and filling material for specified endodontic applications. ^[47][52]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Endodontic material

Sealer Solvent ↗

Endodontic solvent product for root-canal workflows. ^[47][51]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Products with unconfirmed commercial availability

Legacy irrigant presentations

Earlier Vista Dental prefilled irrigants ↗

Historical syringe presentations covered by FDA event 83435. ^[47]

Commercial availability not established

Affected historical presentations; current SKU status not established.

Commercial development

Selected commercial group portfolio; legal applicants and legacy recall presentations are kept distinct. ^[47]

Known Distribution Partners

5 partners

Publicly documented relationships; coverage may be incomplete.

Partner	Territory / scope	Products
Benco Dental Supply ^[55]	United States	VistaApex dental portfolio; exact product coverage not disclosed
Darby Dental Supply ^[55]	United States	VistaApex dental portfolio; exact product coverage not disclosed
Dental City ^[55]	United States	VistaApex dental portfolio; exact product coverage not disclosed
Henry Schein ^[55]	United States	VistaApex dental portfolio; exact product coverage not disclosed
Patterson Dental Supply ^[55]	United States	VistaApex dental portfolio; exact product coverage not disclosed

Sources checked October 17, 2026.

55 Cited Sources

Accessed 10/20/2026

[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record

[2] FDA K010544 — VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE ↗U.S. Food and Drug Administration · regulatory record

[3] FDA K010547 — VERTEX SEALAND L/C ORTHODONTIC SEALANT ↗U.S. Food and Drug Administration · regulatory record

[4] FDA K010849 — VERTEX ETCHANT ↗U.S. Food and Drug Administration · regulatory record

[5] FDA K020570 — SIMPLICITY ↗U.S. Food and Drug Administration · regulatory record

[6] FDA K053103 — INTERFACE ↗U.S. Food and Drug Administration · regulatory record

[7] FDA K061981 — SURPASS ↗U.S. Food and Drug Administration · regulatory record

[8] FDA K062157 — CONFORM ↗U.S. Food and Drug Administration · regulatory record

[9] FDA K082470 — SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA ↗U.S. Food and Drug Administration · regulatory record

[10] FDA K091647 — INJECTAFIL ↗U.S. Food and Drug Administration · regulatory record

[11] FDA K092539 — SEAMFREE ↗U.S. Food and Drug Administration · regulatory record

[12] FDA K110859 — METAL OPAQUER ↗U.S. Food and Drug Administration · regulatory record

[13] FDA K112250 — CHX=CHX PLUS ↗U.S. Food and Drug Administration · regulatory record

[14] FDA K120620 — CLEAN AND BOOST ↗U.S. Food and Drug Administration · regulatory record

[15] FDA K131043 — APEX UNIVERSAL ADHESIVE ↗U.S. Food and Drug Administration · regulatory record

[16] FDA K131049 — ZRP ↗U.S. Food and Drug Administration · regulatory record

[17] FDA K161077 — RnD TE and RnD SE ↗U.S. Food and Drug Administration · regulatory record

[18] FDA K170101 — Valiant Curing Light ↗U.S. Food and Drug Administration · regulatory record

[19] FDA K190220 — Vista FS, Vista FS Liquid ↗U.S. Food and Drug Administration · regulatory record

[20] FDA K190998 — BA Pit & Fissure Sealant ↗U.S. Food and Drug Administration · regulatory record

[21] FDA K193357 — V-Mix ↗U.S. Food and Drug Administration · regulatory record

[22] FDA K193389 — Vista Clear ↗U.S. Food and Drug Administration · regulatory record

[23] FDA K193409 — Vista Rinse, Vista Rinse Plus ↗U.S. Food and Drug Administration · regulatory record

[24] FDA K193447 — Vista Dyes ↗U.S. Food and Drug Administration · regulatory record

[25] FDA K211721 — PS System ↗U.S. Food and Drug Administration · regulatory record

[26] FDA K211813 — Triton ↗U.S. Food and Drug Administration · regulatory record

[27] FDA K221811 — Vista BC Sealer ↗U.S. Food and Drug Administration · regulatory record

[28] FDA K241354 — Sealer Solvent ↗U.S. Food and Drug Administration · regulatory record

[29] FDA K241457 — Vista BC Putty ↗U.S. Food and Drug Administration · regulatory record

[30] FDA K241489 — ReminGel ↗U.S. Food and Drug Administration · regulatory record

[31] FDA K253337 — REGEN Bioactive Cement ↗U.S. Food and Drug Administration · regulatory record

[32] FDA De Novo database — research search ↗FDA / openFDA · regulatory record

[33] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[34] FDA PMA database — research search ↗FDA / openFDA · regulatory record

[35] FDA recall Z-0011-2020 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[36] FDA recall Z-0012-2020 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[37] FDA recall Z-0013-2020 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[38] FDA recall Z-0014-2020 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[39] FDA recall Z-0015-2020 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[40] FDA recall Z-0016-2020 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[41] FDA recall Z-0017-2020 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[42] FDA recall Z-2400-2026 — Inter-Med Llc ↗U.S. Food and Drug Administration · regulatory record

[43] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record

[44] FDA UDI database — research search ↗FDA / openFDA · regulatory record

[45] Vista Apex Solutions ↗VistaApex Solutions · company website

[46] Dental Products – Vista Apex Solutions ↗VistaApex Solutions · company website

[47] Brand and product portfolio ↗VistaApex Solutions · company website

[48] Hiring source review ↗VistaApex Solutions · company website

[49] Active role: Field Sales Manager - Distribution Development ↗VistaApex Solutions · company website

[50] Active role: Production Assembly Worker ↗VistaApex Solutions · company website

[51] FDA 510(k) K241354 ↗U.S. Food and Drug Administration · regulatory database

[52] FDA 510(k) K241457 ↗U.S. Food and Drug Administration · regulatory database

[53] FDA recall Z-0017-2020 ↗U.S. Food and Drug Administration · regulatory database

[54] CEO appointment ↗VistaApex Solutions · company website

[55] VistaApex North American dealer directory ↗VistaApex · company website

VistaApex Solutions

Company overview

Leadership

Products & regulatory status How does MedTechIndex get this information?

Summary

Regulatory snapshot How to read this snapshot

Commercial portfolio snapshot

PinkWave QuadWave Curing Light ↗

Vista BC Putty ↗

Sealer Solvent ↗

Products with unconfirmed commercial availability

Earlier Vista Dental prefilled irrigants ↗

Commercial development

Known Distribution Partners

55 Cited Sources

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