FDA.reportPublic FDA data

EXPERIENCE®

Primary DI
D788202C3500301
Brand
EXPERIENCE®
Company
Gc Orthodontics America Inc.
Model
20-2C35-0030
Catalog number
20-2C35-0030
Device description
EXP XT 022 U/L 5-5 HK U3, L345
Published
2020-09-08
Public version status
New
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
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D788202C3500301PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
063167128
Device count
1
Premarket exempt
true
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
00190707192976Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192983Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192990Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193003Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193010Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193027Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190746141249Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141263Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141454Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141461Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141515Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141522Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175442Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175459Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746161575Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746174957Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175268Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175275Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175503Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175510Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26