FDA.reportPublic FDA data

LINING CEMENT

Primary DI
D0470001081
Brand
LINING CEMENT
Company
Gc America Inc.
Model
000108
Catalog number
000108
Device description
LINING CEMENT 15 g liquid
Published
2016-08-01
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
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K85146800076 EMA LINING CEMENTG-C Intl. Corp.1985-05-01EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0470001082PackageHIBCC5In Commercial Distribution
D0470001081PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity linerA substance intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth from chemical irritation. The device is typically a thin layer of zinc oxide (ZnO) and eugenol (C10H12O2), or calcium hydroxide (Ca(OH)2). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume12Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
10386040013437EXA Advanced1381121381122022-08-12
10386040013444EXA Advanced1381131381132022-08-12
10386040013451EXA Advanced1381161381162022-08-12
10386040013468EXA Advanced1381171381172022-08-12
10386040013475EXA Advanced1381181381182022-08-12
10386040013482EXA Advanced1381191381192022-08-12
10386040013871EQUIA®4520034520032022-07-13
D6581200011COE ALGINATE™1200011200012016-08-01
D6581201011COE ALGINATE™1201011201012016-08-01
D6581210011COE ALGINATE™1210011210012016-08-01
D6581211011COE ALGINATE™1211011211012016-08-01
D6581240011COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241011COE HYDROPHILIC GEL™1241011241012016-08-01
D6581310021COE-FLEX®1310021310022016-08-01
D6581310031COE-FLEX®1310031310032016-08-01
D6581310041COE-FLEX®1310041310042016-08-01

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Primary DI, Brand, Company table
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08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
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08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
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07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
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