FDA.reportPublic FDA data

AELITE Anterior Syringe Kit

Primary DI
D757H81210K1
Brand
AELITE Anterior Syringe Kit
Company
BISCO INC.
Model
H-81210K
Catalog number
H-81210K
Published
2017-06-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBDCoating, filling material, resin
EBFMATERIAL, TOOTH SHADE, RESIN
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
EMACEMENT, DENTAL
KLEAGENT, TOOTH BONDING, RESIN
KXRAPPLICATOR, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2
EBFMaterial, Tooth Shade, ResinDental2
EIDSyringe, Restorative And Impression MaterialDental1
EMACement, DentalDental2
KLEAgent, Tooth Bonding, ResinDental2
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757H81210K1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resin kitA collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
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
06954454000045COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454000267COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454000748COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454004784COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454005842COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454006979COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454006986COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454006993COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06954454007006COTISENHuanghua Promisee Dental Co., Ltd.KXR2026-10-26
06970006745660Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006745677Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746568Phosphoric Acid Etching GelRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006746575TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746582TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746599TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746605TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746612TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746629TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746636TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746643TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746650TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746674TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746681TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746698TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746704Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746711Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746728Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746735Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746742Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25