FDA.reportPublic FDA data

DTC

Primary DI
06973554430163
Brand
DTC
Company
Hangzhou DTC Medical Apparatus Co., Ltd.
Model
0.022
Device description
Delicate series 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
06973554430163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973554430163069735544301636973554430163

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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
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
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