FDA.report

N/A

Primary DI
10195291008099
Brand
N/A
Company
FLEXMEDICS
Model
KTRCR2255A
Device description
CRMC ROTH 5-5 KIT 022
Published
2020-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10195291008099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019529100809910195291008099

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
317-346-6655ORDERS@GHORTHO.COM

Regulatory Flags

DUNS number
028853567
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00195291000010N/A125-L1-2U-V2020-05-27
00195291000027N/A125-L1-8U-V2020-05-27
00195291000232N/A125-U3-2LK-V2020-05-28
00195291000294N/A125-U4-8LK-V2020-05-28
10195291000314N/A125K-345-18-012020-05-27
00195291000416N/A126-L4-8LK-V2020-05-27
00195291000614N/A126-U4-8LK-V2020-05-28
00195291000652N/A75-L1-2U-V2020-05-27
00195291000669N/A75-L1-8U-V2020-05-27
00195291000683N/A75-L3-2RK-V2020-05-28
00195291000720N/A75-L4-2RK-V2020-05-27
00195291000737N/A75-L4-2U-V2020-05-28
00195291000744N/A75-L4-8LK-V2020-05-27
00195291000768N/A75-L4-8U-V2020-05-27
10195291001038N/A75K-345-18-012020-05-27
00195291001055N/A76-L1-2U-V2020-05-27
00195291001062N/A76-L1-8U-V2020-05-27
00195291001109N/A76-L3-2RK0-V2020-05-27
00195291001123N/A76-L3-8LK0-V2020-05-27
00195291001130N/A76-L3-8RK-V2020-05-27

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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
00190746198632Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198649Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23