FDA.reportPublic FDA data

DTC

Primary DI
06973554430057
Brand
DTC
Company
Hangzhou DTC Medical Apparatus Co., Ltd.
Model
0.022
Device description
Self-ligating brackets
Published
2021-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
06973554430057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973554430057069735544300576973554430057

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracketA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. 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
525905364
Device count
1
Premarket exempt
true
Lot or batch
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973554430019DTCLSL74-172021-12-06
06973554430026DTC0.0182021-12-06
06973554430033DTC0.0222021-12-06
06973554430064DTC0.0182021-12-06
06973554430071DTC0.0222021-12-06
06973554430088DTC0.0182021-12-06
06973554430095DTC0.0222021-12-06
06973554430101DTC0.0182021-12-06
06973554430125DTC0.0182021-12-06
06973554430132DTC0.0222021-12-06
06973554430149DTC0.0222021-12-06
06973554430156DTC0.0182021-12-06
06973554430163DTC0.0222021-12-06
06973554430170DTC0.018/0.0222021-12-06
06973554430187DTC0.018/0.0222021-12-06
06973554430194DTC0.018/0.0222021-12-06
06973554430200DTC0.018/0.0222021-12-06
06973554430217DTC0.018/0.0222021-12-06
06973554430224DTC0.018/0.022/Φ0.0452021-12-06
06973554430231DTC0.018/0.022/Φ0.0452021-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707192976Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192983Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192990Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193003Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193010Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193027Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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00190746174957Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175268Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175275Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175503Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175510Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26