EXPERIENCE® 19-1BB5-8997

GUDID D788191BB589971

EXMRC Roth/MBT 018 U/L 6-6 HK345

Gc Orthodontics America Inc.

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal
Primary Device IDD788191BB589971
NIH Device Record Key7ea4c940-ab76-4535-ad0f-04c78b37974a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPERIENCE®
Version Model Number19-1BB5-8997
Catalog Number19-1BB5-8997
Company DUNS063167128
Company NameGc Orthodontics America Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]
HIBCCD788191BB589971 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [EXPERIENCE®]

D788242CC500101EXP METAL MINI RC ROTH 022/U5-5/L5-5HK
D788242CC300201EXP METAL MINI RC MBT 022/U5-5/L5
D788242CC300101EXP ME MINI RC ROTH022/U5-5/L5-5 3HK
D78824261000201EXRC MBT 022/L1&2 -6T 0A
D78824245D00201EXRC MBT 022/LR5 -17T 2A HK
D78824245000201EXRC MBT 022/LR5 -17T 2A
D78824244D00201EXRC MBT 022/LR4 -12T 2A HK
D78824244000201EXRC MBT 022/LR4 -12T 2A
D78824243D00201EXM MBT 022/LR3 -6T 3A HK
D78824235D00201EXRC MBT 022/LL5-17T 2A HK
D78824235000201EXRC MBT 022/LL5 -17T 2A
D78824234D00201EXRC MBT 022/LL4 -12T 2A HK
D78824234000201EXRC MBT 022/LL4 -12T 2A
D78824233D00201EXM MBT 022/LL3 -6T 3A HK
D78824224D00201EXRC MBT 022/UL4&5 -7T 0A HK
D78824223D00201EXRC MBT 022/UL3 -7T 8A HK
D78824222000201EXRC MBT 022/UL2 10T 8A
D78824221000201EXRC MBT 022/UL1 17T 4A
D78824214D00201EXRC MBT 022/UR4&5 -7T 0A HK
D78824213D00201EXRC MBT 022/UR3 -7T 8A HK
D78824212000201EXRC MBT 022/UR2 10T 8A
D78824211000201EXRC MBT 022/UR1 17T 4A
D78824161000201EXRC MBT 018/L1&2 -6T 0A
D78824145D00201EXRC MBT 018/LR5 -17T 2A HK
D78824144D00201EXRC MBT 018/LR4 -12T 2A HK
D78824143D00201EXRC MBT 018/LR3 -6T 3A HK
D78824135D00201EXRC MBT 018/LL5-17T 2A HK
D78824134D00201EXRC MBT 018/LL4 -12T 2A HK
D78824133D00201EXRC MBT 018/LL3 -6T 3A HK
D78824124D00201EXRC MBT 018/UL4&5 -7T 0A HK
D78824123D00201EXRC MBT 018/UL3 -7T 8A HK
D78824122000201EXRC MBT 018/UL2 10T 8A
D78824121000201EXRC MBT 018/UL1 17T 4A
D78824114D00201EXRC MBT 018/UR4&5 -7T 0A HK
D78824113D00201EXRC MBT 018/UR3 -7T 8A HK
D78824112000201EXRC MBT 018/UR2 10T 8A
D78824111000201EXRC MBT 018/UR1 17T 4A
D78821541000101EXP Mini TGO 020X028/LR1&2-1T 2A 0O
D78821531000101EXP Mini TGO 020X028 LL1&2-1T 2A 0O
D78821522000101EXPERIENCE Mini TGO 020X028/UL2 8T 9A
D78821521000101EXPERIENCE Mini TGO 020X028/UL1 12T 5A
D78821512000101EXPERIENCE Mini TGO 020X028/UR2 8T 9A
D78821511000101EXMP TGO 020X028/UR1 12T 5A
D78821461000201EXMP MBT 022/L1&2 -6T 0A
D78821445D00201EXMP MBT 022/LR5 -17T 2A HK
D78821445D00101EXMP ROTH 022/LR5 -22T -1A 4D HK
D78821445000101EXMP ROTH 022/LR5 -22T -1A 4D
D78821444D00201EXMP MBT 022/LR4 -12T 2A HK
D78821444D00101EXMP ROTH 022/LR4 -17T-1A 4D HK
D78821444000101EXMP ROTH 022/LR4 -17T -1A 4D

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.