FDA.reportPublic FDA data

Mico One Orthodontic Wire Clamp

Primary DI
04719896291152
Brand
Mico One Orthodontic Wire Clamp
Company
ZE FANG TECHNOLOGY CO., LTD.
Model
SP-U-0820O
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
04719896291152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719896291152047198962911524719896291152

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic lockA dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
656214227
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719896291077Mico One Orthodontic Wire ClampSP-T-3910X2026-05-19
04719896291084Mico One Orthodontic Wire ClampSP-T-4250X2026-05-19
04719896291091Mico One Orthodontic Wire ClampSP-S-1700X2026-05-19
04719896291107Mico One Orthodontic Wire ClampSP-A-9400X2026-05-19
04719896291114Mico One Orthodontic Wire ClampSP-B-5880X2026-05-19
04719896291121Mico One Orthodontic Wire ClampSP-C-9251X2026-05-19
04719896291138Mico One Orthodontic Wire ClampSP-C-9252X2026-05-19
04719896291145Mico One Orthodontic Wire ClampSP-U-1200O2026-05-19
04719896291169Mico One Orthodontic SpringNS-O-10182026-05-19
04719896291176Mico One Orthodontic SpringNS-O-12182026-05-19
04719896291183Mico One Orthodontic SpringNS-C-10182026-05-19
04719896291190Mico One Orthodontic SpringNS-C-12182026-05-19
04719896291206Mico One Orthodontic SpringTS-M-16222026-05-19
04719896291213Mico One Orthodontic SpringTS-L-16222026-05-19
04719896291220Mico One Orthodontic SpringTS-M-17252026-05-19
04719896291237Mico One Orthodontic SpringTS-L-17252026-05-19
04719896291244Mico One Orthodontic SpringTS-M-18252026-05-19
04719896291251Mico One Orthodontic SpringTS-L-18252026-05-19
04719896291268Mico One Orthodontic SpringTS-M-19252026-05-19
04719896291275Mico One Orthodontic SpringAT-S22026-05-19

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