FDA.report

Bite-Builder

Primary DI
00190730002556
Brand
Bite-Builder
Company
ORTHO TECHNOLOGY, INC.
Model
OT-2350
Device description
Bite-Builder™ 10 per pack
Published
2016-09-24
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
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190730002556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730002556001907300025561907300025560190730002556

GMDN Terms

TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded 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
false
HCT/P
false
Kit
false
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
10190730084535Clear Advantage7500-1002025-07-24
10190730084542Clear Advantage7500-1052025-07-24
10190730084559Clear Advantage7500-1102025-07-24
10190730084566Clear Advantage7500-0352025-07-24
10190730084573Clear Advantage7500-0402025-07-24
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

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