FDA.reportPublic FDA data

STAINLESS STEEL

Primary DI
D78878A2U017220
Brand
STAINLESS STEEL
Company
Gc Orthodontics America Inc.
Model
78-A2UP-1722
Catalog number
78-A2U0-1722
Device description
SS REGULAR FORM A 17X22U
Published
2020-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
D78878A2U017221PrimaryHIBCC0
D78878A2U017220Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. 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

Contacts#

Phone, Email table
PhoneEmail
+1(708)897-8859GCOAInfo@gcorthodontics.com

Regulatory Flags#

DUNS number
063167128
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
false
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
10840539702450Experience50-0300-000050-0300-00002026-05-28
10860013564701Curva50-0041-000050-0041-00002026-05-28
10860013564718Curva50-0040-000050-0041-00002026-05-28
10860013564725Curva50-0512-000050-0041-00002026-05-28
10860013564732Curva50-0513-000050-0041-00002026-05-28
10860013564756Curva50-5610-000050-0041-00002026-05-28
10860013564763Curva50-5000-000050-0041-00002026-05-28
10860013564770Curva50-0043-000050-0041-00002026-05-28
D78887122400001GC Ties87-1224-000087-1224-00002021-08-26
D78887122500001GC Ties87-1225-000087-1225-00002021-08-26
D78887122600001GC Ties87-1226-000087-1226-00002021-08-26
D78887122700001GC Ties87-1227-000087-1227-00002021-08-26
D78887122800001GC Ties87-1228-000087-1228-00002021-08-26
D78887122900001GC Ties87-1229-000087-1229-00002021-08-26
D78887123000001GC Ties87-1230-000087-1230-00002021-08-26
D78887123100001GC Ties87-1231-000087-1231-00002021-08-26
D78887123200001GC Ties87-1232-000087-1232-00002021-08-26
D78887123300001GC Ties87-1233-000087-1233-00002021-08-26
D78887123400001GC Ties87-1234-000087-1234-00002021-08-26
D78887123500001GC Ties87-1235-000087-1235-00002021-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746202841Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202858Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202865Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202872Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202889Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202896Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202902Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202919Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202926Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202933Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202940Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202957Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202964Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202971Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202988Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202995Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203008Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203015Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203022Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203039Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203046Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203053Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203060Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203077Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203084Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203091Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203107Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203114Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203121Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203138Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29