FDA.reportPublic FDA data

Select SE-Bond LC

Primary DI
17540208000162
Brand
Select SE-Bond LC
Company
Zendo Direct AG
Model
SEL-ETCH-LC-5ml
Catalog number
SEL-ETCH-LC-5ml
Device description
One component self-etching light cure adhesive - One-component; 5ml Bottle
Published
2017-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540208000162PackageGS11In Commercial Distribution
07540208000165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754020800016217540208000162
07540208000165075402080001657540208000165

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage temperature: max. 77°F (25°C)

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
486717338
Device count
1
DM exempt
false
Premarket exempt
false
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
07540208000165Select SE-Bond LCSEL-ETCH-LC-5mlSEL-ETCH-LC-5ml2017-09-26
07540208000332Select SupratempTCB-ST-A3TCB-ST-A32018-04-04
17540208000339Select SupratempTCB-ST-A3TCB-ST-A32018-04-04
17540208000391MTA CapsulesZEN-MTA-UNIZEN-MTA-UNI2016-12-15
17540208000407MTA Firm- Normal SetZEN-MTA-FRMNSETZEN-MTA-FRMNSET2017-11-23
17540208000414MTA Firm-Fast SetZEN-MTA-FRMFSTSETZEN-MTA-FRMFSTSET2017-11-23
17540208000421MTA-Flow Fast SetZEN-MTA-FLOFSTZEN-MTA-FLOFST2017-11-23
07540208000011Select Rigid BRRIGBR-LB-SHRIGBR-LB-SH2017-02-21
07540208000059Select NanoFill FIL-RS-A1FIL-RS-A12017-07-05
07540208000066Select NanoFill FIL-RS-A2FIL-RS-A22017-07-05
07540208000073Select NanoFill FIL-RS-A3FIL-RS-A32017-02-21
07540208000219Select Sil Light BodySEL-SIL-LB-SHRS-50SEL-SIL-LB-SHRS-502017-02-21
07540208000226Select Sil Medium BodySEL-SIL-MB-SHRS-PNK5SEL-SIL-MB-SHRS-PNK52017-07-04
07540208000240Select Sil Heavy ViscositySEL-SIL-SHRS-GR50SEL-SIL-SHRS-GR502017-02-21
07540208000356Select Sil Firm PuttySEL-SIL-FR-B400SEL-SIL-FR-B4002017-07-05
07540208000370Select TransbiteSELSIL-TRANS-BSELSIL-TRANS-B2017-11-16
07540208000387Select Calcium Hydroxide Liner LCCAL-LINERCAL-LINER2017-09-26
07540208000448Select Sil Light BodySEL-SIL-LB-SHFS-50SEL-SIL-LB-SHFS-502017-03-07
07540208000455Select Sil Heavy ViscositySEL-SIL-SHFS-GR50SEL-SIL-SHFS-GR502017-03-07
07540208000462Select Sil Medium BodySEL-SIL-MB-SHFS-PNK5SEL-SIL-MB-SHFS-PNK52017-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970006745660Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006746568Phosphoric Acid Etching GelRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06972220488958Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
00840456224366JMUJMU DENTAL, INCKLE2026-07-22
00840456224441JMUJMU DENTAL, INCKLE2026-07-22
07615208570830Adhese 2 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-07-22
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015614Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00850194007763Zr-P BottleVista DentalKLE2026-06-04
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14