FDA.report

Votion

Primary DI
00190730000002
Brand
Votion
Company
ORTHO TECHNOLOGY, INC.
Model
350-91-1100
Device description
Votion .018 R UR1 +12T 5A 0O (10PK)
Published
2018-01-08
Public version status
Update
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

Product Codes

CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190730000002PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
781772017
Device count
1
DM exempt
true
Premarket exempt
true
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

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10190730084542Clear Advantage7500-1052025-07-24
10190730084559Clear Advantage7500-1102025-07-24
10190730084566Clear Advantage7500-0352025-07-24
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10190730084580Sports Advantage7500-1652025-07-24
10190730084597Sports Advantage7500-1402025-07-24
00190730084682Ortho TechnologyOT-000-SS2024-09-18
00190730084811Ortho TechnologyOT-000-SS-D2024-09-18
00190730084828Ortho TechnologyOT-2118-SS2024-09-18
00190730084835Ortho TechnologyOT-2118-SSD2024-09-18
00190730084842Ortho TechnologyOT-2122-SS2024-09-18
00190730084859Ortho TechnologyOT-2122-SSD2024-09-18
00190730084354Ortho TechnologyOT-0272024-09-17
00190730084361Ortho TechnologyOT-0282024-09-17
00190730084378Ortho TechnologyOT-2032024-09-17
00190730084385Ortho TechnologyOT-2042024-09-17
00190730084392Ortho TechnologyOT-2062024-09-17
00190730084439Ortho TechnologyOT-2092024-09-17
00190730084507Ortho TechnologyOT-209R2024-09-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00190746191657Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191664Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191671Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191688Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191695Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191701Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191718Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191725Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191732Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191749Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191756Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191763Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191770Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191787Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191794Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191800Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191817Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191824Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191831Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191848Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191855Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191862Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191879Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191886Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191893Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23