Silkon Plus 002-970M

GUDID 00190746003899

COSMETIC SILKON UR CENTRAL 022 T=0 A+5 R=0

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket, plastic, single-use
Primary Device ID00190746003899
NIH Device Record Keyafc9b946-2b37-4f31-b161-04fe46b70117
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilkon Plus
Version Model Number002-970M
Catalog Number002-970M
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746003899 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYWBRACKET, PLASTIC, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-09

On-Brand Devices [Silkon Plus]

00190746004032COSMETIC SILKON MAND ANTERIOR 022 T=0 A+5 R=0 TWIN
00190746004025COSMETIC SILKON MAND ANTERIOR 022 T=0 A-5 R=0 TWIN
00190746004018COSMETIC SILKON MAND ANTERIOR 022 T=0 A=0 R=0 TWIN
00190746004001COSMETIC SILKON LL CUSPID 022 T+5 A+10 R=0 W/HK DIST
00190746003998COSMETIC SILKON LL CUSPID 022 T+5 A+10 R=0
00190746003981COSMETIC SILKON LR CUSPID 022 T+5 A+10 R=0 W/HK DIST
00190746003974COSMETIC SILKON LR CUSPID 022 T+5 A+10 R=0
00190746003967COSMETIC SILKON UL CUSPID 022 T+5 A+10 R=0 W/HK DIST
00190746003950COSMETIC SILKON UL CUSPID 022 T+5 A+10 R=0
00190746003943COSMETIC SILKON UR CUSPID 022 T+5 A+10 R=0 W/HK DIST
00190746003936COSMETIC SILKON UR CUSPID 022 T+5 A+10 R=0
00190746003929COSMETIC SILKON UL LATERAL 022 T=0 A+9 R=0
00190746003912COSMETIC SILKON UR LATERAL 022 T=0 A+9 R=0
00190746003905COSMETIC SILKON UL CENTRAL 022 T=0 A+5 R=0
00190746003899COSMETIC SILKON UR CENTRAL 022 T=0 A+5 R=0
00190746003882COSMETIC SILKON LL CUSPID 018 T+5 A+10 R=0 W/HK DIST
00190746003875COSMETIC SILKON LL CUSPID 018 T+5 A+10 R=0
00190746003868COSMETIC SILKON LR CUSPID 018 T+5 A+10 R=0 W/HK DIST
00190746003851COSMETIC SILKON LR CUSPID 018 T+5 A+10 R=0
00190746003844COSMETIC SILKON UL CUSPID 018 T+5 A+10 R=0 W/HK DIST
00190746003837COSMETIC SILKON UL CUSPID 018 T+5 A+10 R=0
00190746003820COSMETIC SILKON UR CUSPID 018 T+5 A+10 R=0 W/HK DIST
00190746003813COSMETIC SILKON UR CUSPID 018 T+5 A+10 R=0
00190746003806COSMETIC SILKON UL LATERAL 018 T=0 A+9 R=0
00190746003790COSMETIC SILKON UR LATERAL 018 T=0 A+9 R=0
00190746003783COSMETIC SILKON UL CENTRAL 018 T=0 A+5 R=0
00190746003776COSMETIC SILKON UR CENTRAL 018 T=0 A+5 R=0
00190746003769COSMETIC SILKON UR BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746003752COSMETIC SILKON UL BICUSPID 022 T-7 A=0 R=0 W/HK DIST
00190746003745COSMETIC SILKON MAX BICUSPID 022 T-7 A=0 R=0
00190746003738COSMETIC SILKON LL CUSPID 022 T=0 A+10 R=0 W/HK DIST
00190746003721COSMETIC SILKON LL CUSPID 022 T=0 A+10 R=0
00190746003714COSMETIC SILKON LR CUSPID 022 T=0 A+10 R=0 W/HK DIST
00190746003707COSMETIC SILKON LR CUSPID 022 T=0 A+10 R=0
00190746003691COSMETIC SILKON MAND ANTERIOR 022 T=0 A=0 R=0 SINGLE WING
00190746003684COSMETIC SILKON MAND ANTERIOR 022 T=0 A=0 R=0 TRI WING
00190746003677COSMETIC SILKON UL CUSPID 022 T=0 A+10 R=0 W/HK DIST
00190746003660COSMETIC SILKON UL CUSPID 022 T=0 A+10 R=0
00190746003653COSMETIC SILKON UR CUSPID 022 T=0 A+10 R=0 W/HK DIST
00190746003646COSMETIC SILKON UR CUSPID 022 T=0 A+10 R=0
00190746003639COSMETIC SILKON UL LATERAL 022 T+8 A+9 R=0
00190746003622COSMETIC SILKON UR LATERAL 022 T+8 A+9 R=0
00190746003615COSMETIC SILKON UL CENTRAL 022 T+15 A+5 R=0
00190746003608COSMETIC SILKON UR CENTRAL 022 T+15 A+5 R=0
00190746003592COSMETIC SILKON MAND ANTERIOR 018 T=0 A+5 R=0 TWIN
00190746003585COSMETIC SILKON MAND ANTERIOR 018 T=0 A-5 R=0 TWIN
00190746003578COSMETIC SILKON MAND ANTERIOR 018 T=0 A=0 R=0 TWIN
00190746003561COSMETIC SILKON UR BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746003554COSMETIC SILKON UL BICUSPID 018 T-7 A=0 R=0 W/HK DIST
00190746003547COSMETIC SILKON MAX BICUSPID 018 T-7 A=0 R=0
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.