FDA.reportPublic FDA data

eCement Adhesive Cement Kit

Primary DI
D757C52400K1
Brand
eCement Adhesive Cement Kit
Company
BISCO INC.
Model
C-52400K
Catalog number
C-52400K
Published
2017-06-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757C52400K1PrimaryHIBCC0

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 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
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
true
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
00810111543323QuantiumH-100A2SH-100A2S2025-07-29
00810111543330QuantiumH-110A2SH-110A2S2025-07-29
00810111543347QuantiumH-110A2PSH-110A2PS2025-07-29
10810111541500Aelite Aesthetic EnamelH-852B4H-852B42023-01-16
10810111541548Aelite Aesthetic EnamelH-852FRH-852FR2023-01-16
10810111542255eCementC-5201C-52012023-01-17
20810111541606Aelite Aesthetic EnamelH-854A4H-854A42023-01-16
20810111541637Aelite Aesthetic EnamelH-854B3H-854B32023-01-16
20810111541644Aelite Aesthetic EnamelH-854B4H-854B42023-01-16
20810111541651Aelite Aesthetic EnamelH-854D2H-854D22023-01-16
20810111541668Aelite Aesthetic EnamelH-854D4H-854D42023-01-16
20810111541682Aelite Aesthetic EnamelH-854FRH-854FR2023-01-16
10810111542996QuantiumH-100A1H-100A12025-07-14
10810111543009QuantiumH-100A2H-100A22025-07-14
10810111543016QuantiumH-100A3H-100A32025-07-14
10810111543023QuantiumH-100A35H-100A352025-07-14
10810111543030QuantiumH-100B1H-100B12025-07-14
10810111543047QuantiumH-100B2H-100B22025-07-14
10810111543054QuantiumH-130BLCH-130BLC2025-07-14
10810111543061QuantiumH-110A1H-110A12025-07-14

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Primary DI, Brand, Company table
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