Glidewell RMGI Cement

Primary DI
D745701198PVC00030
Brand
Glidewell RMGI Cement
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1198-PVC0003
Catalog number
70-1198-PVC00030
Device description
Glidewell RMGI cement 2X0.4gm
Published
2022-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
021228671
Device count
2
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
false
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
D745701047COM00580Inclusive70-1047-COM005870-1047-COM00582015-10-24
D745701155BXA00010BruxZir70-1155-BXA000170-1155-BXA00012016-09-23
D745701155BXA00030BruxZir70-1155-BXA000370-1155-BXA00032016-09-23
D745701155BXA00040BruxZir70-1155-BXA000470-1155-BXA00042016-09-23
D745701155BXA00050BruxZir70-1155-BXA000570-1155-BXA00052016-09-23
D745701155BXA00060BruxZir70-1155-BXA000670-1155-BXA00062016-09-23
D745701155BXA00070BruxZir70-1155-BXA000770-1155-BXA00072016-09-23
D745701155BXA00080BruxZir70-1155-BXA000870-1155-BXA00082016-09-23
D745701155BXA00090BruxZir70-1155-BXA000970-1155-BXA00092016-09-23
D745701155BXA00100BruxZir70-1155-BXA001070-1155-BXA00102016-09-23
D745701155BXA00110BruxZir70-1155-BXA001170-1155-BXA00112016-09-23
D745701155BXA00120BruxZir70-1155-BXA001270-1155-BXA00122016-09-23
D745701155BXA00140BruxZir70-1155-BXA001470-1155-BXA00142016-09-23
D745701155BXA00150BruxZir70-1155-BXA001570-1155-BXA00152016-09-23
D745701155BXA00160BruxZir70-1155-BXA001670-1155-BXA00162016-09-23
D745701155BXA00170BruxZir70-1155-BXA001770-1155-BXA00172016-09-23
D745701155BXA00190BruxZir70-1155-BXA001970-1155-BXA00192016-09-23
D745701155BXA00210BruxZir70-1155-BXA002170-1155-BXA00212016-09-23
D745701155BXA00220BruxZir70-1155-BXA002270-1155-BXA00222016-09-23
D745701155BXA00240BruxZir70-1155-BXA002470-1155-BXA00242016-09-23

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