FDA.reportPublic FDA data

EXPERIENCE®

Primary DI
D78819233D00201
Brand
EXPERIENCE®
Company
Gc Orthodontics America Inc.
Model
19-233D-0020
Catalog number
19-233D-0020
Device description
EXMRC MBT 022/LL3 - 6T 3A HK
Published
2017-04-24
Public version status
Update
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
D78819233D00201PrimaryHIBCC0
D78819233D00200Unit of UseHIBCC0

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
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
E53585043111111ELASTICS85-0431-111195-0431-11112021-08-26
E53585044111111ELASTICS85-0441-111185-0441-11112021-08-26
E53585063111111ELASTICS85-0631-111185-0631-11112021-08-26
E53585064111111ELASTICS85-0641-111196-0641-11112021-08-26
E53585083111111ELASTICS85-0831-111185-0831-11112021-08-26
E53585084111111ELASTICS85-0841-111185-0841-11112021-08-26
D78889312200001ELASTIC THREAD89-3122-000089-3122-00002021-12-03
D78889313200001ELASTIC THREAD89-3132-000089-3132-00002021-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908470707678KIT LAUNCH - U-CLIPORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211286METAL BRACKET U-CLIP INTERACTIVE MBT 0.022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211859METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U1RL - (11/21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211866METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3L/L3R (23/43) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211873METAL BRACKET PREMIUM ELITE MBT 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212689METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212696METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213525METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - (12/22/31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213570METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3R/L3L (13/33) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213921METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U3RL/U45RL/L345L/L345R - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611215253METAL BRACKET U-CLIP DUAL PLUS – 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
00190746191602Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191619Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191626Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191633Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191640Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23