FDA.reportPublic FDA data

Stainless Steel Archwire, Euro II, .016, Upper

Primary DI
86941673534891
Brand
Stainless Steel Archwire, Euro II, .016, Upper
Company
Astar Orthodontics Inc.
Model
6161-1600-II
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
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941673534895PrimaryGS10
86941673534891Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941673534895069416735348956941673534895
8694167353489186941673534891

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547794613
Device count
10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25
00840456210123JMUJMU DENTAL, INCDZC2026-06-25
00840456210130JMUJMU DENTAL, INCDZC2026-06-25
00840456211182JMUJMU DENTAL, INCDZC2026-06-25
00840456211199JMUJMU DENTAL, INCDZC2026-06-25
00840456211205JMUJMU DENTAL, INCDZC2026-06-25
00840456211212JMUJMU DENTAL, INCDZC2026-06-25