Smart Advantage GI Sample A1 and A2 pk

Primary DI
00858290006444
Brand
Smart Advantage GI Sample A1 and A2 pk
Company
ELEVATE ORAL CARE, LLC
Model
675UD0200
Device description
Smart Advantage GI Sample A1 and A2 pk
Published
2019-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895386000GLASIONScientific Pharmaceuticals, Inc.1990-04-16EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858290006451PackageGS11In Commercial Distribution
00858290006468PackageGS11In Commercial Distribution
00858290006444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858290006451008582900064518582900064510858290006451
00858290006468008582900064688582900064680858290006468
00858290006444008582900064448582900064440858290006444

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

Regulatory Flags#

DUNS number
002863526
Device count
1
Lot or batch
true

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