FDA.report

Experience

Primary DI
E53511122000301
Brand
Experience
Company
Gc Orthodontics America Inc.
Model
11-1220-0030
Catalog number
11-1220-0030
Device description
EXC XT 018/UL2 10T 8A
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NJMBracket, ceramic, orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E53511122000301PrimaryHIBCC0
E53511122000300Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(708)897-8859GCOAInfo@gcorthodontics.com

Regulatory Flags

DUNS number
063167128
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D78811201CC511201EXPERIENCE11/20-1CC5-112011/20-1CC5-11202023-03-30
D78811202AA597521EXPERIENCE11/20-2AA5-975211/20-2AA5-97522023-03-30
D78812202AA519151EXPERIENCE12/20-2AA5-191512/20-2AA5-19152023-03-30
D788122C0500101EXPERIENCE12-2C05-001012-2C05-00102023-03-30
D788151CC5S0101CHIC15-1CC5-S01015-1CC5-S0102023-03-30
D788152CC5S0101CHIC15-2CC5-S01015-2CC5-S0102023-03-30
D788312BB5GP201LEGEND31-2BB5-GP2031-2BB5-GP202023-03-30
D788312CC542191LEGEND31-2CC5-421931-2CC5-42192023-03-30
D788312CC579391LEGEND31-2CC5-793931-2CC5-79392023-03-30
D78855016001550Rodney55-0160-015555-0160-01552023-03-30
D78892500100001MULTI FA92-5001-000092-5001-00002023-03-30
D78892500200001MULTI FA92-5002-000092-5002-00002023-03-30
D78892500300001MULTI FA92-5003-000092-5003-00002023-03-30
D78892500400001MULTI FA92-5004-000092-5004-00002023-03-30
D78892500500001MULTI FA92-5005-000092-5005-00002023-03-30
D78855016000010Chewies55-0160-000155-0160-00012023-01-25
D78855016000020Chewies55-0160-000255-0160-00022023-01-25
D78855016000030Chewies55-0160-000355-0160-00032023-01-25
D78855016000040Chewies55-0160-000455-0160-00042023-01-25
D78811202AA525611EXPERIENCE11/20-2AA5-256111/20-2AA5-25612023-03-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07908611202772CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2026-05-26
07908611211422KIT CERAMIC BRACKET ICERAM-P MBT 0.022 - 1 SET + TUBES + WIRESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2026-05-26
00190746198359Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198366Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198373Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198380Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198397Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198403Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198410Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198427Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198434Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198441Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198458Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198465Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198472Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198489Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198496Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198502Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198519Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198526Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198533Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198540Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198557Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198564Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198571Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198588Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198595Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198601Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198618Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198625Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23