James Lee

FDA Filings

This page includes the latest FDA filings for James Lee. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004730002
FEI Number3004730002
NameJames Lee
Owner & OperatorDB Orthodontics Ltd
Contact AddressUnit 6, Ryefield Way Silsden
Keighley GB-NOTA BD20 0EF GB
US Agent
Importing Logistics Registration
ImporterDB Orthodontics, Inc.
Address1550 Hotel Circle North Suite 130
San Diego, CA 92108 UNITED STATES
Email Addressjames.lee@dbortho.com
Phone1 619 8927233
FAX1 619 3304885
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1550 Hotel Circle North Suite 130
San Diego, CA 92108 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Foreign Private Label Distributor

Registration Number3010780319
FEI Number3010780319
NameJAMES LEE
Owner & OperatorYu Gwang Precision
Contact Address85 Gongdan Ro 3
Buk-gu KR-27 Daegu Gwangyeogsi 702-815 KR
Official Correspondent
  • In Jo Ryu
  • 82-53-3575512-x
US Agent
Importing Logistics Registration
ImporterYTS Global Inc
Address7406 ALBAN STATION COURT,SUITE A108
Springfield, VA 22150 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7406 ALBAN STATION CT STE A108
Springfield, VA 22150 US
Establishment TypeManufacture Medical Device

Registration Number3011298181
FEI Number3011298181
NameJAMES LEE
Owner & OperatorUnispatech Co., Ltd.
Contact Address42-10 Taejanggongdan-Gil
Wonju-si KR-42 Gangweondo 220962 KR
Official Correspondent
  • Jungdong Lee
  • 82-033-7489064-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7406 ALBAN STATION COURT SUITE A108
Springfield, VA 22150 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
James Lee [DB Orthodontics Ltd]
Mini Mold2017-04-28
James Lee [DB Orthodontics Ltd]
DB Orthodontics Bondable Buttons2017-04-28
James Lee [DB Orthodontics Ltd]
DB Orthodontics Instruments2016-12-16
James Lee [DB Orthodontics Ltd]
DB Orthodontics debonding bur2016-12-15
James Lee [DB Orthodontics Ltd]
Evolve Bracket2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics retractor2016-12-15
James Lee [DB Orthodontics Ltd]
Ultralock impression tray2016-12-15
James Lee [DB Orthodontics Ltd]
Metal impression tray2016-12-15
James Lee [DB Orthodontics Ltd]
Locktight impression tray2016-12-15
James Lee [DB Orthodontics Ltd]
Exacto-Bite2016-12-15
James Lee [DB Orthodontics Ltd]
Interproximal reduction system and accesories2016-12-15
James Lee [DB Orthodontics Ltd]
Airo Strips2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics preformed spring2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics distalizing spring2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics coil spring2016-12-15
James Lee [DB Orthodontics Ltd]
Ixion Safe Cinch2016-12-15
James Lee [DB Orthodontics Ltd]
DB22-0478 - Direct Bond Eyelets2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics lingual cleat2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics archwire stop2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Spiral hook2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Crimpable archwire hook2016-12-15
James Lee [DB Orthodontics Ltd]
Evolve Band2016-12-15
James Lee [DB Orthodontics Ltd]
Wonders of the World Intra Oral Elastics - Non Latex2016-12-15
James Lee [DB Orthodontics Ltd]
Wonders of the World Intra Oral Elastics - Latex2016-12-15
James Lee [DB Orthodontics Ltd]
Duoring Elastomeric Ligatures2016-12-15
James Lee [DB Orthodontics Ltd]
DB03-1130 DB Orthodontics Solid Thread .030 - Clear2016-12-15
James Lee [DB Orthodontics Ltd]
DB03-1125 DB Orthodontics Solid Thread .025 ? Clear2016-12-15
James Lee [DB Orthodontics Ltd]
DB03-0130 DB Orthodontics Hollow Thread .030 - Clear2016-12-15
James Lee [DB Orthodontics Ltd]
DB03-0125 DB Orthodontics Hollow Thread .025 ? Clear2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Radiopaque Separators2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Mini Elastomeric Ligatures2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Extra Oral Latex Elastics2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Elastomeric Ligatures2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontic Rotation Wedges2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontic E Link Modules2016-12-15
James Lee [DB Orthodontics Ltd]
Colour Boutique Ligatures2016-12-15
James Lee [DB Orthodontics Ltd]
Colour Boutique Chain2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics mirror2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Contrastor2016-12-15
James Lee [DB Orthodontics Ltd]
Ixion hand instruments2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics hand instruments2016-12-15
James Lee [DB Orthodontics Ltd]
Evolve Tubes2016-12-15
James Lee [DB Orthodontics Ltd]
Evolve Flow Tubes2016-12-15
James Lee [DB Orthodontics Ltd]
Straight 8 Retainer Wire2016-12-15
James Lee [DB Orthodontics Ltd]
Quad Helix2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics wire ligatures2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Archwires2016-12-15
James Lee [DB Orthodontics Ltd]
DB Orthodontics Archwire (Reel)2016-12-15
James Lee [DB Orthodontics Ltd]
DB Ball Clasps 1.0mm DBL2-00102016-12-15
James Lee [DB Orthodontics Ltd]
DB Ball Clasps 0.9mm DBL2-00092016-12-15
James Lee [DB Orthodontics Ltd]
DB Ball Clasps 0.8mm DBL2-00082016-12-15
James Lee [DB Orthodontics Ltd]
DB Ball Clasps 0.7mm DBL2-00072016-12-15
James Lee [DB Orthodontics Ltd]
DB Ball Clasps 0.6mm DBL2-00062016-12-15
James Lee [DB Orthodontics Ltd]
Australian Wire2016-12-15
James Lee [DB Orthodontics Ltd]
Nola Dry Field System2016-12-15
JAMES LEE [Unispatech Co., Ltd.]
Theranova2015-12-11
JAMES LEE [Unispatech Co., Ltd.]
Theranova2015-01-12
JAMES LEE [Yu Gwang Precision]
Health Bar2014-06-18
James Lee [DB Orthodontics Ltd]
Infinitas mini implant Sterile2014-06-17
JAMES LEE [Yu Gwang Precision]
Transfer Lift YGM-0022014-05-07
James Lee [DB Orthodontics Ltd]
Infinitas mini-implant system2007-11-07
James Lee [DB Orthodontics Ltd]
IXION2004-08-16

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020081885608Yantian,China (Mainland) -> Los Angeles, CaliforniaBRIDE VEIL WITH COMB1 PCS
20200811110015Yantian,China (Mainland) -> Los Angeles, CaliforniaHAIR REMOVAL CREAM1 PCS
2020060322736Yantian,China (Mainland) -> Oakland, CaliforniaHAIR TRIMMER 12JJ00005GD D81 PCS
2020052566829Yantian,China (Mainland) -> Oakland, CaliforniaLED GROW LIGHT1 PCS
2020050475295Yantian,China (Mainland) -> Oakland, CaliforniaBAR DOG NET OAIJSD61 PCS
20200501116130Yantian,China (Mainland) -> Oakland, CaliforniaTHE PORTABLE BAG1 PCS
2020050153364Yantian,China (Mainland) -> Oakland, CaliforniaCHEST EXPANDER NCYD00002 S011 PCS
2020050190928Yantian,China (Mainland) -> Oakland, CaliforniaTOOL1 PCS
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