FDA.reportPublic FDA data

Thino Roth Bracket, .022 Mini, LL4, w/o hook

Primary DI
06941673501668
Brand
Thino Roth Bracket, .022 Mini, LL4, w/o hook
Company
Astar Orthodontics Inc.
Model
1212-034
Published
2023-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
06941673501668PrimaryGS10
86941673501664Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941673501668069416735016686941673501668
8694167350166486941673501664

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.

Regulatory Flags#

DUNS number
547794613
Device count
50
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941673501453Thino Roth Bracket, .022, Mini Size, UL11212-0112023-12-31
06941673501460Thino Roth Bracket, .022, Mini Size, UL21212-0122023-12-31
06941673501477Thino Roth Bracket, .022 Mini, UL3, w/hk at distal1212-013Hd2023-12-31
06941673501484Thino Roth Bracket, .022 Mini, UL4, w/o hook1212-0142023-12-31
06941673501491Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial1212-014Hm2023-12-31
06941673501507Thino Roth Bracket, .022 Mini, UL4, w/hk at distal1212-014Hd2023-12-31
06941673501514Thino Roth Bracket, .022 Mini, UL5, w/o hook1212-0152023-12-31
06941673501521Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial1212-015Hm2023-12-31
06941673501538Thino Roth Bracket, .022 Mini, UL5, w/hk at distal1212-015Hd2023-12-31
06941673501545Thino Roth Bracket, .022, Mini Size, UR11212-0212023-12-31
06941673501552Thino Roth Bracket, .022, Mini Size, UR21212-0222023-12-31
06941673501576Thino Roth Bracket, .022 Mini, UR4, w/o hook1212-0242023-12-31
06941673501583Thino Roth Bracket, .022 Mini, UR4, w/hk at mesial1212-024Hm2023-12-31
06941673501590Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-024Hd2023-12-31
06941673501606Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-0252023-12-31
06941673501613Thino Roth Bracket, .022 Mini, UR5, w/hk at mesial1212-025Hm2023-12-31
06941673501620Thino Roth Bracket, .022 Mini, UR5, w/hk at distal1212-025Hd2023-12-31
06941673501637Thino Roth Bracket, .022, Mini Size, LL11212-0312023-12-31
06941673501644Thino Roth Bracket, .022, Mini Size, LL21212-0322023-12-31
06941673501651Thino Roth Bracket, .022 Mini, LL3, w/hk at distal1212-033Hd2023-12-31

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