CHIC 14-1C05-S010

GUDID D788141C05S0101

Chic Roth 018 U 5-5 HK 345

Gc Orthodontics America Inc.

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic
Primary Device IDD788141C05S0101
NIH Device Record Key987534a9-1a69-4570-b3d0-cccc53c35171
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHIC
Version Model Number14-1C05-S010
Catalog Number14-1C05-S010
Company DUNS063167128
Company NameGc Orthodontics America Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]
HIBCCD788141C05S0101 [Primary]

FDA Product Code

NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, orthodontic
NJMBracket, ceramic, 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 [CHIC]

D788142EE300101CHIC ROTH 022/U3-3/L3-3, 3HK
D788142E0300201CHIC MBT 022/U3-3, 3HK
D788142E0300101CHIC ROTH 022/U3-3, 3HK
D788142CE500201CHIC MBT 022/U5-5/L3-3, 3,4,5HK
D788142CE500101Chic ROTH 022/U5-5/L3-3, 3,4,5HK
D788142CE300201CHIC MBT 022/U5-5/L3-3, 3HK
D788142CE300101Chic ROTH 022/U5-5/L3-3, 3HK
D788142CC3SK011CHIC/LMI ROTH 022/U5-5/L5-5 SK
D788142C0500201CHIC MBT 022/U5-5, 3,4,5HK
D788142C0500101Chic ROTH 022/U5-5, 3,4,5HK
D788142C0300201CHIC MBT 022/U5-5, 3HK
D788142C0300101Chic ROTH 022/U5-5, 3HK
D78814265000201CHIC MBT 022/L5 -17T 0A 0D
D78814265000101CHIC ROTH 022/L5 -22T 0A 0D
D78814264000201CHIC MBT 022/L4 -12T 0A 0D
D78814264000101CHIC ROTH 022/L4 -17T 0A 0D
D78814261000201CHIC MBT 022/L1&2 -6T 0A
D78814261000101CHIC ROTH 022/L1&2 0T 0A
D78814255U00201CHIC MBT 022/U5 -7T 0A 0D HK
D78814255000201CHIC MBT 022/U5 -7T 0A 0D
D78814254U00201CHIC MBT 022/U4&5 -7T 0A 0D HK
D78814254U00101CHIC ROTH 022/U4&5 -7T 0A 0D HK
D78814254000201CHIC MBT 022/U4&5 -7T 0A 0D
D78814254000101CHIC ROTH 022/U4&5 -7T 0A 0D
D78814245D00201CHIC MBT 022/LR5 -17T 0A 0D HK
D78814245D00101CHIC ROTH 022/LR5 -22T 0A 0D HK
D78814244D00201CHIC MBT 022/LR4 -12T 0A 0D HK
D78814244D00101CHIC ROTH 022/LR4 -17T 0A 0D HK
D78814243D00201CHIC MBT 022/LR3 -6T 3A HK
D78814243D00101CHIC ROTH 022/LR3 -11T 7A 2M HK
D78814243000101CHIC ROTH 022/LR3 -11T 7A 2M
D78814235D00201CHIC MBT 022/LL5 -17T 0A 0D HK
D78814235D00101CHIC ROTH 022/LL5 -22T 0A 0D HK
D78814234D00201CHIC MBT 022/LL4 -12T 0A 0D HK
D78814234D00101CHIC ROTH 022/LL4 -17T 0A 0D HK
D78814233D00201CHIC MBT 022/LL3 -6T 3A HK
D78814233D00101CHIC ROTH 022/LL3 -11T 7A 2M HK
D78814233000101CHIC ROTH 022/LL3 -11T 7A 2M
D78814223D00201CHC MBT 022/UL3 -7T 8A HK
D78814223D00101CHIC ROTH 022/UL3 -2T 13A 4M HK
D78814223000101CHIC ROTH 022/UL3 -2T 13A 4M
D78814222000201CHIC MBT 022/UL2 10T 8A
D78814222000101CHIC ROTH 022/UL2 8T 9A 0OF
D78814221000201CHIC MBT 022/UL1 17T 4A
D78814221000101CHIC ROTH 022/UL1 12T 5A 0OF
D78814213D00201CHIC MBT 022/UR3 -7T 8A HK
D78814213D00101CHIC ROTH 022/UR3 -2T 13A 4M HK
D78814213000101CHIC ROTH 022/UR3 -2T 13A 4M
D78814212000201CHIC MBT 022/UR2 10T 8A
D78814212000101CHIC ROTH 022/UR2 8T 9A 0OF

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