High-Q-Bond Adhesive Resin Cement Automix

Primary DI
07290115050370
Brand
High-Q-Bond Adhesive Resin Cement Automix
Company
B.J.M. LABORATORIES LTD
Model
100050AM
Published
2023-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933766000HIGH-Q-BONDSilmet U.S.A. Corp.1994-01-26EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115050370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115050370072901150503707290115050370

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature024 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514764117
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115050400High-Q-Bond SE100050SE2026-03-20
07290115050523BJM Root Canal Sealer4002002026-03-20
07290115050356Quick Seal1001302026-03-13
07290115050035High-Q-Bond Bracket Adhesive4000632026-03-13
07290115050196Prima Quick Prime1002102026-03-13
07290115053340Quick Seal1001302026-03-13
07290115051889Smile Stream STEP-1 PumEtch9000-10002026-03-13
07290115051896Ideal 1 Orthodontic Bracket Adhesive52-800-102026-03-13
07290115051902High-Q-Bond Band4000662026-03-13
07290115050141Multi Bond1000462023-11-22
07290115050158Multi Bond1000472023-11-22
07290115052886Auto-Cure Activator1000602023-11-22
07290115050448Porcelain Fix4000842023-11-22
07290115050462Porcelain Silane4000832023-11-22
07290115050479Porcelain Etch4000822023-11-22

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08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
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08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
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