FDA.reportPublic FDA data

DTC

Primary DI
06973554430941
Brand
DTC
Company
Hangzhou DTC Medical Apparatus Co., Ltd.
Model
L121
Device description
Lingual super-elastic NiTi arch wire
Published
2021-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ECNClamp, Wire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973554430941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973554430941069735544309416973554430941

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456204962JMUJMU DENTAL, INCECN2026-06-25
00840456204979JMUJMU DENTAL, INCECN2026-06-25
00840456204986JMUJMU DENTAL, INCECN2026-06-25
00840456204993JMUJMU DENTAL, INCECN2026-06-25
00840456205006JMUJMU DENTAL, INCECN2026-06-25
00840456205013JMUJMU DENTAL, INCECN2026-06-25
00840456205266JMUJMU DENTAL, INCECN2026-06-25
00840456205273JMUJMU DENTAL, INCECN2026-06-25
00840456205280JMUJMU DENTAL, INCECN2026-06-25
00840456205754JMUJMU DENTAL, INCECN2026-06-25
00840456205761JMUJMU DENTAL, INCECN2026-06-25
00840456205778JMUJMU DENTAL, INCECN2026-06-25
00840456205785JMUJMU DENTAL, INCECN2026-06-25
00840456205792JMUJMU DENTAL, INCECN2026-06-25
00840456205808JMUJMU DENTAL, INCECN2026-06-25
00840456205815JMUJMU DENTAL, INCECN2026-06-25
00840456205822JMUJMU DENTAL, INCECN2026-06-25
00840456205839JMUJMU DENTAL, INCECN2026-06-25
00840456205846JMUJMU DENTAL, INCECN2026-06-25
00840456205853JMUJMU DENTAL, INCECN2026-06-25
00840456205860JMUJMU DENTAL, INCECN2026-06-25
00840456206072JMUJMU DENTAL, INCECN2026-06-25
00840456206355JMUJMU DENTAL, INCECN2026-06-25
00840456221730JMUJMU DENTAL, INCECN2026-05-11
00840456221747JMUJMU DENTAL, INCECN2026-05-11
006522210993343M™ Unitek™ Intraoral Attachments3M UNITEK CORPORATIONECN2026-05-07
00190746203770Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203787Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203794Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203800Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21