FDA.reportPublic FDA data

Smartwire InGager

Primary DI
00850018135399
Brand
Smartwire InGager
Company
SWIFT HEALTH SYSTEMS INC.
Model
85001
Catalog number
85001
Device description
An orthodontic reusable instrument intended for use with the InBrace Teeth Straightening System (Gen 2.0) to insert, ligate and remove Smartwires from brackets.
Published
2021-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018135399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018135399008500181353998500181353990850018135399

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracket open/close toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
884398210
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018135122Inbrace Teeth Straightening System Digital Engancement81312022-10-03
00850018135009Inbrace Teeth Straightening System Standard Patient Kit81012021-11-07
00850018135016Inbrace Teeth Straightening System Upper Patient Kit81112021-11-07
00850018135030InBrace Teeth Straightening System (Gen 2.0)Upper Fitting Kit850022021-11-07
00850018135047InBrace Teeth Straightening System (Gen 2.0)Fitting Kit850002021-11-07
00850018135054InBrace Teeth Straightening System (Gen 2.0)Lower Fitting Kit850032021-11-07
00850018135139Inbrace Teeth Straightening System Lower Patient Kit81212021-11-07
10850018135396InBrace Starter Kit 83000830002021-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000069COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000076COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000083COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000090COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000106COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000113COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001509COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001684COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001691COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001707COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001714COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001721COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001738COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001745COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015315COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015322COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015339COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015346COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015353COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015971COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015988COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000052COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-27
00083208130380Scissors Dean T/C CurvedSuncoast Dental, IncDZN2026-10-07
00816594025448CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025462CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025714CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
07908854001750Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854001835Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854018079Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25