MEDENTiKA

GUDID EMKAH5002

Solid abutment

MEDENTiKA GmbH

Dental implant suprastructure, permanent, preformed

• Primary Device ID: EMKAH5002
• NIH Device Record Key: 33b07e86-221d-4125-a290-6f70084eb388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDENTiKA
• Version Model Number: H 500-2
• Company DUNS: 537555497
• Company Name: MEDENTiKA GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com
• Phone: +1(855)412-8883
• Email: Info.us@instradent.com

Device Dimensions

• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0
• Angle: 18 degree
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMKAH5002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142167

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-30

On-Brand Devices [MEDENTiKA]

• EMKAT902016R9: PreFace abutment incl. Screw
• EMKAT9010R9: PreFace abutment incl. Screw
• EMKAT901016R9: PreFace abutment incl. Screw
• EMKAT9005R9: PreFace abutment incl. Screw
• EMKAT900516R9: PreFace abutment incl. Screw
• EMKAT9000R9: PreFace abutment incl. Screw
• EMKAT310R9: Castable gold abutment incl. Screw
• EMKAT305R9: Castable gold abutment incl. Screw
• EMKAT300R9: Castable gold abutment incl. Screw
• EMKAT10209: Titanium base incl. Screw
• EMKAT10109: Titanium base incl. Screw
• EMKAT10059: Titanium base incl. Screw
• EMKAT10009: Titanium base incl. Screw
• EMKAS9030R9: PreFace abutment incl. Screw
• EMKAS9020R9: PreFace abutment incl. Screw
• EMKAS902016R9: PreFace abutment incl. Screw
• EMKAS9000R9: PreFace abutment incl. Screw
• EMKAS900016R9: PreFace abutment incl. Screw
• EMKAS320R9: Castable gold abutment incl. Screw
• EMKAS300R9: Castable gold abutment incl. Screw
• EMKAS12209: Titanium base incl. Screw
• EMKAS12009: Titanium base incl. Screw
• EMKAS10209: Titanium base incl. Screw
• EMKAS10009: Titanium base incl. Screw
• EMKAR902016R9: PreFace abutment incl. Screw
• EMKAR9010R9: PreFace abutment incl. Screw
• EMKAR901016R9: PreFace abutment incl. Screw
• EMKAR9000R9: PreFace abutment incl. Screw
• EMKAR900016R9: PreFace abutment incl. Screw
• EMKAR10209: Titanium base incl. Screw
• EMKAR10109: Titanium base incl. Screw
• EMKAR10009: Titanium base incl. Screw
• EMKAN9030R9: PreFace abutment incl. Screw
• EMKAN9020R9: PreFace abutment incl. Screw
• EMKAN902016R9: PreFace abutment incl. Screw
• EMKAN9010R9: PreFace abutment incl. Screw
• EMKAN901016R9: PreFace abutment incl. Screw
• EMKAN320R9: Castable gold abutment incl. Screw
• EMKAN310R9: Castable gold abutment incl. Screw
• EMKAN300R9: Castable gold abutment incl. Screw
• EMKAN110L9: Standard abutment incl. Screw
• EMKAN10309: Titanium base incl. Screw
• EMKAN10209: Titanium base incl. Screw
• EMKAN10109: Titanium base incl. Screw
• EMKAL9010R9: PreFace abutment incl. Screw
• EMKAL901016R9: PreFace abutment incl. Screw
• EMKAL9000R9: PreFace abutment incl. Screw
• EMKAL900016R9: PreFace abutment incl. Screw
• EMKAL310R9: Castable gold abutment incl. Screw
• EMKAL300R9: Castable gold abutment incl. Screw