FDA.reportPublic FDA data

G-aenial™

Primary DI
15400556015190
Brand
G-aenial™
Company
Gc America Inc.
Model
952243
Catalog number
952243
Device description
G-aenial A'CHORD Syringe AE
Published
2022-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, tooth shade, resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123631000MFP-051GC America, Inc.2013-07-23EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15400556015190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1540055601519015400556015190

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.

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
00386040015243Foundation27-500-10027-500-1002024-03-12
00386040015250Foundation27-500-20027-500-2002024-03-12
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
14548161312134Cytrans Granules0143600143602022-08-12
14548161312141Cytrans Granules0143610143612022-08-12
14548161312158Cytrans Granules0143620143622022-08-12
14548161312165Cytrans Granules0143630143632022-08-12
14548161312172Cytrans Granules0143640143642022-08-12
04548161312137Cytrans Granules100075160143602022-04-01
04548161312144Cytrans Granules100075170143612022-04-01
04548161312151Cytrans Granules100075180143622022-04-01
04548161312168Cytrans Granules100075190143632022-04-01
04548161312175Cytrans Granules100075200143642022-04-01
D0470143601Cytrans Granules100075160143602022-04-01
D0470143611Cytrans Granules100075170143612022-04-01
D0470143621Cytrans Granules100075180143622022-04-01
D0470143631Cytrans Granules100075190143632022-04-01

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00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
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00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
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08806383541046DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541060DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
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08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
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