FDA.reportPublic FDA data

Gold Tone

Primary DI
00190746136795
Brand
Gold Tone
Company
AMERICAN ORTHODONTICS CORPORATION
Model
856-718
Catalog number
856-718
Device description
WIRE SS GOLD TONE SPOOL 018 30 FEET
Published
2018-10-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
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
00190746136795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746136795001907461367951907461367950190746136795

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
Device count
1
DM exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746170829Separators854-034080854-0340802021-06-11
00190746189258Buccal Tubes851-110851-1102022-03-24
00190746189272Buccal Tubes851-121851-1212022-03-24
00190746189432Buccal Tubes851-182851-1822022-03-24
00190746141249Stainless Steel Brackets002-0070HMURWF002-0070HMURWF2021-09-03
00190746141263Stainless Steel Brackets002-0071HMULWF002-0071HMULWF2021-09-03
00190746141454Stainless Steel Brackets002-477HDLLWF002-477HDLLWF2021-09-03
00190746141461Stainless Steel Brackets002-477HDLRWF002-477HDLRWF2021-09-03
00190746141515Stainless Steel Brackets002-494HDLLWF002-494HDLLWF2021-09-03
00190746141522Stainless Steel Brackets002-494HDLRWF002-494HDLRWF2021-09-03
00190746175442Stainless Steel Brackets092-208BUL092-208BUL2021-09-03
00190746175459Stainless Steel Brackets092-208BUR092-208BUR2021-09-03
00190746176296Stainless Steel Brackets097-211UL097-211UL2021-09-03
00190746176302Stainless Steel Brackets097-211UR097-211UR2021-09-03
00190746177996Stainless Steel Brackets593-004593-0042021-09-03
00190746161575Stainless Steel Brackets091-142BUL091-142BUL2021-08-26
00190746174957Stainless Steel Brackets091-142BUR091-142BUR2021-08-26
00190746175268Stainless Steel Brackets092-006BUL092-006BUL2021-08-26
00190746175275Stainless Steel Brackets092-006BUR092-006BUR2021-08-26
00190746175503Stainless Steel Brackets092-444HDLR092-444HDLR2021-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011520120000Noninium®DENTAURUM GmbH & Co.KGDZC2026-09-04
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