Vista-Cal Refill Kit

FDA UDI

Class II (US FDA UDI)

by Vista Dental

Identity

Trade Name: Vista-Cal Refill Kit FDA UDI
Generic Name: Dental etching solution FDA UDI
Device Name: 12.5 pH aqueous solution for temporary filling and cleansing root canals. Refill kit includes (20) 1.2mL prefilled high pressure syringes. FDA UDI
Model / Reference: 502601 FDA UDI
Description: 12.5 pH aqueous solution for temporary filling and cleansing root canals. Refill kit includes (20) 1.2mL prefilled high pressure syringes. FDA UDI

Identifiers

Primary DI / UDI-DI: 20818207020202 FDA UDI
510(k) Number: K963922 FDA UDI
FDA Product Code: KIF FDA UDI
GMDN Term: Dental etching solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental etching solution

Vista-Cal Refill Kit by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental etching solution.

Dento-Etch — Spident · Class IIa
Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
DC Keramik Ätzgel — PRISMAN GmbH · Class I
MASTER-DENT — DENTONICS, INC.
OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
ETCHANT — Pulpdent Corporation · Class II
Scotchbond™ Universal — 3M Deutschland GmbH · Class II
GC CERAMIC PRIMER II — Gc America Inc. · Class II

Cleared under the same submission

K963922 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Vista Dental

Sources (1)

FDA UDI ddfc5d9e-c10e-4e10-84ee-e4fd51533349 34 fields · synced May 30, 2026