RadiancePlus 126-032253

GUDID 00190746152665

1 PAT SETUP RADIANCE MBT 018 U/L 5X5 W/HK 3 UL3 T-7 DROP-IN

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket, ceramic
Primary Device ID00190746152665
NIH Device Record Key1246d528-5eaf-4363-a3ee-e5588d9539ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadiancePlus
Version Model Number126-032253
Catalog Number126-032253
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746152665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [RadiancePlus]

00190746002816COSMETIC RADIANCE LTS UL LATERAL 018 T+8 A+9 R=0
00190746002809COSMETIC RADIANCE LTS UR LATERAL 018 T+8 A+9 R=0
00190746002793COSMETIC RADIANCE LTS UL CENTRAL 018 T+12 A+5 R=0
00190746002786COSMETIC RADIANCE LTS UR CENTRAL 018 T+12 A+5 R=0
00190746002779COSMETIC RADIANCE LTS LL 2ND BICUSPID 018 T-9 A=0 R=0
00190746002762COSMETIC RADIANCE LTS LR 2ND BICUSPID 018 T-9 A=0 R=0
00190746002755COSMETIC RADIANCE LTS LL 1ST BICUSPID 018 T-7 A=0 R=0
00190746002748COSMETIC RADIANCE LTS LR 1ST BICUSPID 018 T-7 A=0 R=0
00190746002731COSMETIC RADIANCE LTS LL CUSPID 018 T-7 A+6 R=0
00190746002724COSMETIC RADIANCE LTS LR CUSPID 018 T-7 A+6 R=0
00190746002717COSMETIC RADIANCE LTS LL LATERAL 018 T-5 A+6 R=0 W/HK
00190746002700COSMETIC RADIANCE LTS LL LATERAL 018 T-5 A+6 R=0
00190746002694COSMETIC RADIANCE LTS LR LATERAL 018 T-5 A+6 R=0 W/HK
00190746002687COSMETIC RADIANCE LTS LR LATERAL 018 T-5 A+6 R=0
00190746002670COSMETIC RADIANCE LTS LL CENTRAL 018 T-5 A+2 R=0
00190746002663COSMETIC RADIANCE LTS LR CENTRAL 018 T-5 A+2 R=0
00190746002656COSMETIC RADIANCE LTS UL 2ND BICUSPID 018 T-8 A+4 R=0
00190746002649COSMETIC RADIANCE LTS UR 2ND BICUSPID 018 T-8 A+4 R=0
00190746002632COSMETIC RADIANCE LTS UL 1ST BICUSPID 018 T-7 A=0 R=0
00190746002625COSMETIC RADIANCE LTS UR 1ST BICUSPID 018 T-7 A=0 R=0
00190746002618COSMETIC RADIANCE LTS UL CUSPID 018 T-3 A+10 R=0
00190746002601COSMETIC RADIANCE LTS UR CUSPID 018 T-3 A+10 R=0
00190746002595COSMETIC RADIANCE LTS UL LATERAL 018 T+8 A+9 R=0 W/HK DIST
00190746002588COSMETIC RADIANCE LTS UL LATERAL 018 T+8 A+9 R=0
00190746002571COSMETIC RADIANCE LTS UR LATERAL 018 T+8 A+9 R=0 W/HK DIST
00190746002564COSMETIC RADIANCE LTS UR LATERAL 018 T+8 A+9 R=0
00190746002557COSMETIC RADIANCE LTS UL CENTRAL 018 T+15 A+5 R=0
00190746002540COSMETIC RADIANCE LTS UR CENTRAL 018 T+15 A+5 R=0
00190746002533COSMETIC RADIANCE LL 2ND BICUSPID 022 T-11 A=0 R=0 W/HK DIST
00190746002526COSMETIC RADIANCE LR 2ND BICUSPID 022 T-11 A=0 R=0 W/HK DIST
00190746002519COSMETIC RADIANCE MAND 2ND BICUSPID 022 T-11 A=0 R=0
00190746002502COSMETIC RADIANCE LL 1ST BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746002496COSMETIC RADIANCE LR 1ST BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746002489COSMETIC RADIANCE MAND 1ST BICUSPID 022 T-7 A=0 R=0
00190746002472COSMETIC RADIANCE UL BICUSPID 022 T=0 A=0 R=0 W/HK DIST
00190746002465COSMETIC RADIANCE UR BICUSPID 022 T=0 A=0 R=0 W/HK DIST
00190746002458COSMETIC RADIANCE MAX BICUSPID 022 T=0 A=0 R=0
00190746002441COSMETIC RADIANCE UL LATERAL 022 T+14 A+8 R=0 W/HK DIST
00190746002434COSMETIC RADIANCE UL LATERAL 022 T+14 A+8 R=0
00190746002427COSMETIC RADIANCE UR LATERAL 022 T+14 A+8 R=0 W/HK DIST
00190746002410COSMETIC RADIANCE UR LATERAL 022 T+14 A+8 R=0
00190746002403COSMETIC RADIANCE UL CENTRAL 022 T+22 A+5 R=0
00190746002397COSMETIC RADIANCE UR CENTRAL 022 T+22 A+5 R=0
00190746002380COSMETIC RADIANCE LL 2ND BICUSPID 018 T-11 A=0 R=0 W/HK DIST
00190746002373COSMETIC RADIANCE LR 2ND BICUSPID 018 T-11 A=0 R=0 W/HK DIST
00190746002366COSMETIC RADIANCE MAND 2ND BICUSPID 018 T-11 A=0 R=0
00190746002359COSMETIC RADIANCE LL 1ST BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746002342COSMETIC RADIANCE LR 1ST BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746002335COSMETIC RADIANCE MAND 1ST BICUSPID 018 T-7 A=0 R=0
00190746002328COSMETIC RADIANCE UL BICUSPID 018 T=0 A=0 R=0 W/HK DIST

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