FDA.reportPublic FDA data

Mico One Dental hand instrument

Primary DI
04719896293538
Brand
Mico One Dental hand instrument
Company
ZE FANG TECHNOLOGY CO., LTD.
Model
AO-BK-OP00130
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
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719896293538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719896293538047198962935384719896293538

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracket open/close toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

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
04719896291152Mico One Orthodontic Wire ClampSP-U-0820O2026-05-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000069COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000076COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000083COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000090COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000106COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000113COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001509COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001684COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001691COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001707COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001714COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001721COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001738COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454001745COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015315COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015322COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015339COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015346COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015353COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015971COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454015988COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-28
06954454000052COTISENHuanghua Promisee Dental Co., Ltd.DZN2026-10-27
00083208130380Scissors Dean T/C CurvedSuncoast Dental, IncDZN2026-10-07
00816594025448CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025462CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025714CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
07908854001750Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854001835Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854018079Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25