FDA.reportPublic FDA data

ZrC Syringe Kit

Primary DI
10818207020984
Brand
ZrC Syringe Kit
Company
Vista Dental
Model
90782
Published
2022-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMEExternal Cleaning Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMEExternal Cleaning SolutionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818207020987Direct MarkingGS10
10818207020984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818207020987008182070209878182070209870818207020987
1081820702098410818207020984

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration fixation cleaning solutionA non-sterile liquid substance intended to be used to extra-orally clean the adherent surface of a dental restorative/prosthetic device (e.g., veneer, crown, inlay, onlay), after it has been assessed in situ as a trial, to improve adhesion when it is permanently fixed in place. The solution is typically a water-based gel containing potassium hydroxide supplied in a syringe with a number of applicator tips. It is not intended to be used as a tooth etching solution. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
2626339755info@vista-dental.com

Regulatory Flags#

DUNS number
036623932
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818207024920Endo Sealer Solvent3170332026-04-22
10818207024944Endo Sealer Solvent Sample317033-M2026-04-22
00850194007862Desensify12019-12-13
00850194007893Omni Etch Ceramic Etch and Silane12019-12-13
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207025071Endocator Starter Kit4077302025-11-07
10818207025088Endocator Swabs (20pk)4077312025-11-07
10818207025064ReminGelRGEL30002025-10-09
10818207020205Vista-Cal Standard Kit5026002018-07-31
10818207020878Velvet Etch 5033152021-05-13
30818207020872Velvet Etch 5033002021-05-13
00850194007787Purify+ Gel 5 Pack12019-12-13
00850194007794Purify+ Liquid 5 Pack12019-12-13
00850194007954Purify+ Gel Single Pack12019-12-13
00850194007961Purify+ Liquid Single Pack12019-12-13
20818207020202Vista-Cal Refill Kit5026012018-07-31
00850194007466RE-GEN Cleanser1907192016-06-16
00818207020208Vista-Cal 2 pack Foil Pouch36272018-08-28
10818207024968Traxodent Gel AlCl - Bulk Syringe Kit90071012025-06-30
10818207024975Traxodent Gel AlCl - Sample Pack90071042025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972220484332Hydrofluoric Acid Etching GelRizhao HuGe Biomaterials Company, Ltd.PME2025-10-27
06972220485803Hydrofluoric Acid Etching GelRizhao HuGe Biomaterials Company, Ltd.PME2025-10-27
10818207025040UniCleanVista DentalPME2025-06-30
00810111542470ZirCleanBISCO INC.PME2022-07-29
00810111542487ZirCleanBISCO INC.PME2022-07-29
07540172000765Detail™ Pre-Impression Cleansing GelCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.PME2022-02-18
00818207020970ZrC BottleVista DentalPME2022-01-10
00818207020987ZrC Syringe KitVista DentalPME2022-01-07
EKUR003970KA1KATANA Cleaner KURARAY NORITAKE DENTAL INC.PME2019-12-10
EKUR003971KA1KATANA Cleaner KURARAY NORITAKE DENTAL INC.PME2019-12-10
D757B73510ZirCleanBISCO INC.PME2018-04-17
D757B7351P1ZirCleanBISCO INC.PME2018-04-17
D8374810000Go-CHx Gel - 0.8% ChlorhexidineTaub ProductsPME2016-12-05
D8374810050Go-CHx Gel - 0.8% ChlorhexidineTaub ProductsPME2016-12-05
D8374850000Go-CHx Gel - 0.8% ChlorhexidineTaub ProductsPME2016-12-05
D820RCG0Resolve Cleansing GelDENALI CORPORATIONPME2016-08-04