FDA.reportPublic FDA data

DTC

Primary DI
06973554430187
Brand
DTC
Company
Hangzhou DTC Medical Apparatus Co., Ltd.
Model
0.018/0.022
Device description
Zeal series 2nd molar bondable buccal tube
Published
2021-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973554430187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973554430187069735544301876973554430187

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is 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
06973554430163DTC0.0222021-12-06
06973554430170DTC0.018/0.0222021-12-06
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
00197998070198SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070204SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070211SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075063SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075674SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101670SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101694SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107887SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107900SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253386SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253393SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253409SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253416SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253423SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253430SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253447SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253454SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253461SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253478SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253485SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253492SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253508SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253515SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253522SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253539SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253546SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253553SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253560SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253577SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253584SolventumSolventum Orthodontics CorporationDZD2026-10-24