FDA.reportPublic FDA data

ZrC Syringe Kit

Primary DI
00818207020987
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
OTC
false
Sterile
false
Single use
false

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
036623932
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850194007763Zr-P Bottle905772026-06-04
00818207020840ZrP Syringe Kit905782021-01-29
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

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
10818207020984ZrC 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