FDA.reportPublic FDA data

G-Coating Bracket, Roth .022, LR1

Primary DI
86941673528852
Brand
G-Coating Bracket, Roth .022, LR1
Company
Astar Orthodontics Inc.
Model
MG20-041
Published
2023-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
06941673528856PrimaryGS10
86941673528852Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941673528856069416735288566941673528856
8694167352885286941673528852

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547794613
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 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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00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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