Metal Custom Rx 002-016WF

GUDID 00190746163142

WELDABLE BRACKET NARROW TWIN V-SLOT 022 TQ=0 A=0 R=0 PROFILE=065 M/D=100

AMERICAN ORTHODONTICS CORPORATION

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 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 Orthodontic bracket, metal Orthodontic bracket, metal
Primary Device ID00190746163142
NIH Device Record Key2941b897-36fe-44e8-8b64-033110339b3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMetal Custom Rx
Version Model Number002-016WF
Catalog Number002-016WF
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746163142 [Primary]

FDA Product Code

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 Date2020-10-01
Device Publish Date2020-09-23

On-Brand Devices [Metal Custom Rx]

00190746136726BRACKET LEWIS 022 4.5MM W/020X020 V-SLOT PROFILE=HGW M/D=060 O/G=132
00190746136719BRACKET POSTERIOR WIDTH UNIVERSAL 018 TQ=0 A=0 R=0 PROFILE=060 M/D=100 O/G=134
00190746136702BRACKET LEWIS D 018 +3 ANG +14 TQ POST MAX RT PROFILE=STD M/D=.100 O/G=.134
00190746136696BRACKET LEWIS D 018 +3 ANG +14 TQ POST MAX LEFT PROFILE=STD M/D=.100 O/G=.134
00190746136689BKT CENT "D" SLOT .018 +5 ANG +12 TQ LEWIS 6MM RT PROFILE=STD M/D=.050 O/G=.134
00190746136672BKT CENT "D" SLOT .018 +5 ANG +12 TQ LEWIS 6MM LT PROFILE=STD M/D=.050 O/G=.134
00190746136665BRACKET BEGG 020 FLAT
00190746136658BRACKET MEDIUM TWIN V-SLOT 022 TQ=0 A=0 R=0 PROFILE=065 M/D=100 O/G=134
00190746136641BRACKET SINGLE WIDTH V-SLOT 022 TQ=0 A=0 R=0 PROFILE=STD M/D=080 O/G=134
00190746136634BRACKET INTER TWIN MAND 1ST UNIVERSAL BICUSPID 022 TQ=-11 A=0 R=0 PROFILE=HGW
00190746134142BRACKET SINGLE WIDTH V-SLOT 022 TQ=0 A=0 R=0 PROFILE=STD M/D=080 O/G=134
00190746115073BRACKET MEDIUM TWIN MAX RIGHT/MAND LEFT CUSPID 022 TQ=+7 A=+5 R=0 PROFILE=HP
00190746115066BRACKET INTER TWIN MAX RIGHT BICUSPID 022 TQ=-7 A=0 R=0 HOOK D-G PROFILE=HGW
00190746115059BRACKET INTER TWIN MAX LEFT BICUSPID 022 TQ=-7 A=0 R=0 HOOK D-G PROFILE=HGW
00190746115042BRACKET INTER TWIN MAX RIGHT BICUSPID 018 TQ=0 A=0 R=0 HOOK D-G PROFILE=HGW
00190746115035BRACKET INTER TWIN MAX LEFT BICUSPID 018 TQ=0 A=0 R=0 HOOK D-G PROFILE=HGW
00190746115028WELDABLE BRACKET INTER-TWIN 2ND BICUSPID LEFT 022 TQ=-22 A=0 R=0 HOOK D-G
00190746115011WELDABLE BRACKET INTER-TWIN 2ND BICUSPID RIGHT 022 TQ=-22 A=0 R=0 HOOK D-G
00190746115004WELDABLE BRACKET INTER-TWIN 1ST BICUSPID LEFT 022 TQ=-17 A=0 R=0 HOOK D-G
00190746114991WELDABLE BRACKET INTER-TWIN 1ST BICUSPID RIGHT 022 TQ=-17 A=0 R=0 HOOK D-G
00190746114984WELDABLE BRACKET INTER-TWIN 1ST BICUSPID LEFT 022 TQ=-11 A=0 R=0 HOOK D-G
00190746114977WELDABLE BRACKET INTER-TWIN 1ST BICUSPID RIGHT 022 TQ=-11 A=0 R=0 HOOK D-G
00190746114960WELDABLE BRACKET INTER TWIN MAX LEFT BICUSPID 022 TQ=-7A=0 R=0 HOOK M-G
00190746114953WELDABLE BRACKET INTER TWIN MAX RIGHT BICUSPID 022 TQ=-7A=0 R=0 HOOK M-G
00190746114946WELDABLE BRACKET INTER TWIN MAND LEFT BICUSPID 018 TQ=-11 A=0 R=0 HOOK D-G
00190746114939WELDABLE BRACKET INTER TWIN MAND RIGHT BICUSPID 018 TQ=-11 A=0 R=0 HOOK D-G
00190746114922WELDABLE BRACKET INTER TWIN MAX LEFT BICUSPID 018 TQ=-7 A=0 R=0 HOOK M-G
00190746114915WELDABLE BRACKET INTER TWIN MAX RIGHT BICUSPID 018 TQ=-7 A=0 R=0 HOOK M-G
00190746114908BRACKET INTER-TWIN MAX LEFT BICUSPID 022 TQ=-7 A=0 R=0 HOOK M-G PROFILE=HGW
00190746114892BRACKET MAX R BICUSPID 022 TQ=7 A=0 R=0 HOOK M-G PROFILE=HGW M/D=120 SYSTEM=ROTH
00190746114885WELDABLE BRACKET INTER-TWIN MAND LEFT 2ND BICUSPID 022TQ=-22 A=0 R=0 HOOK D-G
00190746114878WELDABLE BRACKET INTER-TWIN MAND RIGHT 2ND BICUSPID 022 TQ=-22 A=0 R=0 HOOK D-G
00190746114861WELDABLE BRACKET INTER-TWIN MAND LEFT 1ST BICUSPID 022 TQ=-17 A=0 R=0 HOOK D-G
00190746114854WELDABLE BRACKET INTER-TWIN MAND RIGHT 1ST BICUSPID 022 TQ=-17 A=0 R=0 HOOK D-G
00190746114847WELDABLE BRACKET INTER-TWIN MAX LEFT BICUSPID 022TQ=-7 A=0 R=0 HOOK M-G
00190746114830WELDABLE BRACKET INTER-TWIN MAX RIGHT BICUSPID 022 TQ=-7 A=0 R=0 HOOK M-G
00190746114823WELDABLE BRACKET INTER-TWIN MAND LEFT 2ND BICUSPID 018 TQ=-22 A=0 R=0 HOOK D-G
00190746114816WELDABLE BRACKET INTER-TWIN MAND RIGHT 2ND BICUSPID 018 TQ=-22 A=0 R=0 HOOK D-G
00190746114809WELDABLE BRACKET INTER-TWIN MAND LEFT 1ST BICUSPID 018 TQ=-17 A=0 R=0 HOOK D-G
00190746114793WELDABLE BRACKET INTER-TWIN MAND RIGHT 1ST BICUSPID 018 TQ=-17 A=0 R=0 HOOK D-G
00190746114786WELDABLE BRACKET INTER-TWIN MAX LEFT BICUSPID 018 TQ=-7 A=0 R=0 HOOK M-G
00190746114779WELDABLE BRACKET INTER-TWIN MAX RIGHT BICUSPID 018 TQ=-7 A=0 R=0 HOOK M-G
00190746114731BRACKET SGL WIDTH 022 -7 TQ W/020X020 V-SLOT PROFILE= 060 M/D=.080 O/G=.0134
00190746114724BRACKET SGL WIDTH 018 +7 TQ PROFILE=STD M/D=.080 O/G=.0132
00190746114717BRACKET SGL WIDTH 018 -7 TQ PROFILE=HGW M/D=.050 O/G=.132
00190746114649BRACKET SGL WIDTH 018 -17 TQ PROFILE=HGW M/D=.050 O/G=.132
00190746114632BRACKET SGL WIDTH 018 -11 TQ PROFILE= HGW M/D=.050 O/G=.132
00190746114625BRACKET M-TWIN 022 -10 TQ PROFILE=HGW M/D=.080 O/G=.132
00190746114618BRACKET M-TWIN 018 PROFILE=STD BEV M-D= 132 O-G= 134
00190746114601BRACKET M-TWIN 022 25 TQ PROFILE=LOW M/D=.132 O/G=.132

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