FDA.reportPublic FDA data

GC Ortho ConnectTM

Primary DI
E53590110000001
Brand
GC Ortho ConnectTM
Company
Gc Orthodontics America Inc.
Model
90-1100-0000
Catalog number
90-1100-0000
Device description
GC Ortho ConnectTM 2 syringe pack
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
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150128000GC Ortho Connect, GC Ortho Etching GelGc Orthodontics America, Inc.2015-07-16DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E53590110000001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(708)897-8859GCOAInfo@gcorthodontics.com

Regulatory Flags#

DUNS number
063167128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840539702450Experience50-0300-000050-0300-00002026-05-28
10860013564701Curva50-0041-000050-0041-00002026-05-28
10860013564718Curva50-0040-000050-0041-00002026-05-28
10860013564725Curva50-0512-000050-0041-00002026-05-28
10860013564732Curva50-0513-000050-0041-00002026-05-28
10860013564756Curva50-5610-000050-0041-00002026-05-28
10860013564763Curva50-5000-000050-0041-00002026-05-28
10860013564770Curva50-0043-000050-0041-00002026-05-28
D78887122400001GC Ties87-1224-000087-1224-00002021-08-26
D78887122500001GC Ties87-1225-000087-1225-00002021-08-26
D78887122600001GC Ties87-1226-000087-1226-00002021-08-26
D78887122700001GC Ties87-1227-000087-1227-00002021-08-26
D78887122800001GC Ties87-1228-000087-1228-00002021-08-26
D78887122900001GC Ties87-1229-000087-1229-00002021-08-26
D78887123000001GC Ties87-1230-000087-1230-00002021-08-26
D78887123100001GC Ties87-1231-000087-1231-00002021-08-26
D78887123200001GC Ties87-1232-000087-1232-00002021-08-26
D78887123300001GC Ties87-1233-000087-1233-00002021-08-26
D78887123400001GC Ties87-1234-000087-1234-00002021-08-26
D78887123500001GC Ties87-1235-000087-1235-00002021-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073564SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073571SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998062407SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062551SolventumSolventum Orthodontics CorporationDYH2026-10-24
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00197998063169SolventumSolventum Orthodontics CorporationDYH2026-10-24
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00197998063183SolventumSolventum Orthodontics CorporationDYH2026-10-24
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00197998063213SolventumSolventum Orthodontics CorporationDYH2026-10-24
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00197998063329SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063947SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063954SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063961SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063978SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063985SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063992SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998064005SolventumSolventum Orthodontics CorporationDYH2026-10-24