Silkon Plus 002-913MB

GUDID 00190746003318

COSMETIC SILKON LL CUSPID 018 T-5 A+10 R=0 W/HK DIST

AMERICAN ORTHODONTICS CORPORATION

Orthodontic bracket, plastic, single-use

• Primary Device ID: 00190746003318
• NIH Device Record Key: bad14893-363c-455c-86e5-c89a1109e6e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silkon Plus
• Version Model Number: 002-913MB
• Catalog Number: 002-913MB
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com
• Phone: +1(800)558-7687
• Email: info@americanortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746003318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891372

FDA Product Code

• DYW: BRACKET, PLASTIC, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-09

On-Brand Devices [Silkon Plus]

• 00190746004032: COSMETIC SILKON MAND ANTERIOR 022 T=0 A+5 R=0 TWIN
• 00190746004025: COSMETIC SILKON MAND ANTERIOR 022 T=0 A-5 R=0 TWIN
• 00190746004018: COSMETIC SILKON MAND ANTERIOR 022 T=0 A=0 R=0 TWIN
• 00190746004001: COSMETIC SILKON LL CUSPID 022 T+5 A+10 R=0 W/HK DIST
• 00190746003998: COSMETIC SILKON LL CUSPID 022 T+5 A+10 R=0
• 00190746003981: COSMETIC SILKON LR CUSPID 022 T+5 A+10 R=0 W/HK DIST
• 00190746003974: COSMETIC SILKON LR CUSPID 022 T+5 A+10 R=0
• 00190746003967: COSMETIC SILKON UL CUSPID 022 T+5 A+10 R=0 W/HK DIST
• 00190746003950: COSMETIC SILKON UL CUSPID 022 T+5 A+10 R=0
• 00190746003943: COSMETIC SILKON UR CUSPID 022 T+5 A+10 R=0 W/HK DIST
• 00190746003936: COSMETIC SILKON UR CUSPID 022 T+5 A+10 R=0
• 00190746003929: COSMETIC SILKON UL LATERAL 022 T=0 A+9 R=0
• 00190746003912: COSMETIC SILKON UR LATERAL 022 T=0 A+9 R=0
• 00190746003905: COSMETIC SILKON UL CENTRAL 022 T=0 A+5 R=0
• 00190746003899: COSMETIC SILKON UR CENTRAL 022 T=0 A+5 R=0
• 00190746003882: COSMETIC SILKON LL CUSPID 018 T+5 A+10 R=0 W/HK DIST
• 00190746003875: COSMETIC SILKON LL CUSPID 018 T+5 A+10 R=0
• 00190746003868: COSMETIC SILKON LR CUSPID 018 T+5 A+10 R=0 W/HK DIST
• 00190746003851: COSMETIC SILKON LR CUSPID 018 T+5 A+10 R=0
• 00190746003844: COSMETIC SILKON UL CUSPID 018 T+5 A+10 R=0 W/HK DIST
• 00190746003837: COSMETIC SILKON UL CUSPID 018 T+5 A+10 R=0
• 00190746003820: COSMETIC SILKON UR CUSPID 018 T+5 A+10 R=0 W/HK DIST
• 00190746003813: COSMETIC SILKON UR CUSPID 018 T+5 A+10 R=0
• 00190746003806: COSMETIC SILKON UL LATERAL 018 T=0 A+9 R=0
• 00190746003790: COSMETIC SILKON UR LATERAL 018 T=0 A+9 R=0
• 00190746003783: COSMETIC SILKON UL CENTRAL 018 T=0 A+5 R=0
• 00190746003776: COSMETIC SILKON UR CENTRAL 018 T=0 A+5 R=0
• 00190746003769: COSMETIC SILKON UR BICUSPID 022 T-7 A=0 R=0 W/HK DIST
• 00190746003752: COSMETIC SILKON UL BICUSPID 022 T-7 A=0 R=0 W/HK DIST
• 00190746003745: COSMETIC SILKON MAX BICUSPID 022 T-7 A=0 R=0
• 00190746003738: COSMETIC SILKON LL CUSPID 022 T=0 A+10 R=0 W/HK DIST
• 00190746003721: COSMETIC SILKON LL CUSPID 022 T=0 A+10 R=0
• 00190746003714: COSMETIC SILKON LR CUSPID 022 T=0 A+10 R=0 W/HK DIST
• 00190746003707: COSMETIC SILKON LR CUSPID 022 T=0 A+10 R=0
• 00190746003691: COSMETIC SILKON MAND ANTERIOR 022 T=0 A=0 R=0 SINGLE WING
• 00190746003684: COSMETIC SILKON MAND ANTERIOR 022 T=0 A=0 R=0 TRI WING
• 00190746003677: COSMETIC SILKON UL CUSPID 022 T=0 A+10 R=0 W/HK DIST
• 00190746003660: COSMETIC SILKON UL CUSPID 022 T=0 A+10 R=0
• 00190746003653: COSMETIC SILKON UR CUSPID 022 T=0 A+10 R=0 W/HK DIST
• 00190746003646: COSMETIC SILKON UR CUSPID 022 T=0 A+10 R=0
• 00190746003639: COSMETIC SILKON UL LATERAL 022 T+8 A+9 R=0
• 00190746003622: COSMETIC SILKON UR LATERAL 022 T+8 A+9 R=0
• 00190746003615: COSMETIC SILKON UL CENTRAL 022 T+15 A+5 R=0
• 00190746003608: COSMETIC SILKON UR CENTRAL 022 T+15 A+5 R=0
• 00190746003592: COSMETIC SILKON MAND ANTERIOR 018 T=0 A+5 R=0 TWIN
• 00190746003585: COSMETIC SILKON MAND ANTERIOR 018 T=0 A-5 R=0 TWIN
• 00190746003578: COSMETIC SILKON MAND ANTERIOR 018 T=0 A=0 R=0 TWIN
• 00190746003561: COSMETIC SILKON UR BICUSPID 018 T-7 A=0 R=0 W/HK DIST
• 00190746003554: COSMETIC SILKON UL BICUSPID 018 T-7 A=0 R=0 W/HK DIST
• 00190746003547: COSMETIC SILKON MAX BICUSPID 018 T-7 A=0 R=0