FDA.reportPublic FDA data

ZirClean

Primary DI
00810111542470
Brand
ZirClean
Company
BISCO INC.
Model
B-7351
Catalog number
B-7351
Device description
ZIRCLEAN - 5 gram SYRINGE
Published
2022-07-29
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163171000CeraCleanBisco, Inc.2017-04-14PME

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757B73510PreviousHIBCC0
00810111542470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111542470008101115424708101115424700810111542470

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 Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)534-6000sales@bisco.com

Regulatory Flags#

DUNS number
053529939
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111540995Uni-Etch w/BACE-5662E-56622022-10-10
00810111541084Etch-37E-5623EE-5623E2023-01-16
00810111541138Select HV Etch w/BACE-5916E-59162022-10-11
00810111541183Select HV EtchE-5906E-59062022-10-10
D757E5632EBM1UNI-ETCH 32% w/BAC 5gm/TipsE-5632EBME-5632EBM2017-06-12
D757E5638E1ETCH-37 37% 30gm BtlE-5638EE-5638E2017-06-12
D757E56610K1Uni-Etch 32% 30ml KitE-56610KE-56610K2017-06-12
D757E56611P1Uni-Etch 32% 30ml Refill PkgE-56611PE-56611P2017-06-12
D757E56620K1Uni-Etch 32% w/BAC 30ml KitE-56620KE-56620K2017-06-12
D757E56730K1Etch-37 30ml KitE-56730KE-56730K2017-06-12
D757E56731P1Etch-37 30ml Refill PkgE-56731PE-56731P2017-06-12
D757E56740K1Etch-37 w/BAC 30ml KitE-56740KE-56740K2017-06-12
D757E570104% Porcelain Gel Etchant 7gmE-5701E-57012017-06-12
D757E570604% Porcelain Etchant 2mlE-5706E-57062017-06-12
D757E5912PS1Select HV Etch w/BAC 1g Sample Syringe PkgE-5912PSE-5912PS2017-06-12
00810111541190Select HV EtchE-59100KE-59100K2022-11-17
00810111541220Porcelain EtchantE-5701EE-5701E2022-11-17
00810111540988Uni-Etch w/BACE-5637EBE-5637EB2022-10-11
00810111541008Uni-EtchE-5622EE-5622E2022-10-11
00810111541060Etch-37 w/BACE-5638EBE-5638EB2022-10-11

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
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
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