FDA.reportPublic FDA data

Glidewell RMGI Cement

Primary DI
D745701198PVC00031
Brand
Glidewell RMGI Cement
Company
Prismatik Dentalcraft, Inc
Model
70-1198-PVC0003
Catalog number
70-1198-PVC00030
Device description
Glidewell RMGI cement 2X0.4gm
Published
2022-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K011431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011431000RESIN CEMS & C Polymer GmbH2001-06-11EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701198PVC00031PrimaryHIBCC0
D745701198PVC00030Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7256xx@xx.xx

Regulatory Flags#

DUNS number
022761689
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701122SHS01451Obsidian70-1122-SHS014570-1122-SHS01452016-09-23
D745701182BZE05590BruxZir®70-1182-BZE055970-1182-BZE05592026-07-07
D745701182BZE05600BruxZir®70-1182-BZE056070-1182-BZE05602026-07-07
D745701182BZE05610BruxZir®70-1182-BZE056170-1182-BZE05612026-07-07
D745701182BZE05640BruxZir®70-1182-BZE056470-1182-BZE05642026-07-07
D745701182BZE05760BruxZir®70-1182-BZE057670-1182-BZE05762026-07-07
D745701182BZE05770BruxZir®70-1182-BZE057770-1182-BZE05772026-07-07
D745701182BZE05780BruxZir®70-1182-BZE057870-1182-BZE05782026-07-07
D745701182BZE05790BruxZir®70-1182-BZE057970-1182-BZE05792026-07-07
D745701182BZE05820BruxZir®70-1182-BZE058270-1182-BZE05822026-07-07
D745701182BZE05940BruxZir®70-1182-BZE059470-1182-BZE05942026-07-07
D745701182BZE05950BruxZir®70-1182-BZE059570-1182-BZE05952026-07-07
D745701182BZE05960BruxZir®70-1182-BZE059670-1182-BZE05962026-07-07
D745701182BZE05970BruxZir®70-1182-BZE059770-1182-BZE05972026-07-07
D745701182BZE06000BruxZir®70-1182-BZE060070-1182-BZE06002026-07-07
D745701182BZE06120BruxZir®70-1182-BZE061270-1182-BZE06122026-07-07
D745701182BZE06130BruxZir®70-1182-BZE061370-1182-BZE06132026-07-07
D745701182BZE06140BruxZir®70-1182-BZE061470-1182-BZE06142026-07-07
D745701182BZE06150BruxZir®70-1182-BZE061570-1182-BZE06152026-07-07
D745701182BZE06180BruxZir®70-1182-BZE061870-1182-BZE06182026-07-07

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Primary DI, Brand, Company table
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04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
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08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
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