FDA.reportPublic FDA data

Uni-Etch

Primary DI
00810111541015
Brand
Uni-Etch
Company
BISCO INC.
Model
E-5632EM
Catalog number
E-5632EM
Device description
Uni-Etch (32% Phosphoric Acid Etchant) 5g Syr Pkg
Published
2022-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757E5632EM1PreviousHIBCC0
00810111541015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111541015008101115410158101115410150810111541015

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. 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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111543644QuantiumH-102A2PSH-102A2PS2026-10-12
00810111542951AccessoryX-81258X-812582026-10-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998226724Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226731Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226748Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226755Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226762Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226847Solventum™ Garant™Solventum Germany GmbHEID2026-10-08
00810111542951AccessoryBISCO INC.EID2026-10-01
00883205041005Thermo CloneULTRADENT PRODUCTS, INC.EID2026-08-22
08800017902524EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
07615208353723Mixing TipsIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-08-19
00840456224366JMUJMU DENTAL, INCKLE2026-07-22
00840456224441JMUJMU DENTAL, INCKLE2026-07-22
07615208570830Adhese 2 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-07-22
00840456200940JMUJMU DENTAL, INCEID2026-07-20
00840456216743JMUJMU DENTAL, INCEID2026-07-20
00840456218198JMUJMU DENTAL, INCEID2026-07-20
00840456218204JMUJMU DENTAL, INCEID2026-07-20
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-07-14
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015614Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
00850194007763Zr-P BottleVista DentalKLE2026-06-04
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01