FDA.reportPublic FDA data

DTC

Primary DI
06973554430019
Brand
DTC
Company
Hangzhou DTC Medical Apparatus Co., Ltd.
Model
LSL74-17
Device description
IN-Tendo JK-SL lingual 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
06973554430019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973554430019069735544300196973554430019

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
06973554430026DTC0.0182021-12-06
06973554430033DTC0.0222021-12-06
06973554430057DTC0.0222021-12-06
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
00197998062346SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062353SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062360SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062377SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062384SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062391SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062803SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064142SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064159SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064166SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064173SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064180SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064197SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064203SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064272SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064289SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064296SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064302SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064319SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064326SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064333SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064340SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064357SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064364SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064418SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064425SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064432SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064449SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064456SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064463SolventumSolventum Orthodontics CorporationEJF2026-10-24