Slim Line EBS202014

GUDID 08809691368275

Endosseous dental implant

Dentium Co., Ltd.

Screw endosteal dental implant, one-piece

• Primary Device ID: 08809691368275
• NIH Device Record Key: a9076586-102a-4fe3-911d-298b002c9497
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slim Line
• Version Model Number: EBS202014
• Catalog Number: EBS202014
• Company DUNS: 689514395
• Company Name: Dentium Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809691368275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111162

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-30
• Device Publish Date: 2021-08-20

On-Brand Devices [Slim Line]

• 08809162706735: Accessories, Implant, Dental, Endosseousv
• 08809162706728: Accessories, Implant, Dental, Endosseous
• 08809162706704: Accessories, Implant, Dental, Endosseous
• 08809162706681: Accessories, Implant, Dental, Endosseous
• 08809162706674: Accessories, Implant, Dental, Endosseous
• 08809162704830: Accessories, Implant, Dental, Endosseous
• 08809544905596: Chisel, Osteotome, Surgical
• 08809544905589: Chisel, Osteotome, Surgical
• 08809544905572: Chisel, Osteotome, Surgical
• 08809544905565: Chisel, Osteotome, Surgical
• 08809544902236: Accessories, Implant, Dental, Endosseous
• 08809460301748: Chisel, Osteotome, Surgical
• 08809162706759: Chisel, Osteotome, Surgical
• 08809544907491: Accessories, Implant, Dental, Endosseous
• 08809544907484: Accessories, Implant, Dental, Endosseous
• 08809691368619: Endosseous dental implant abutment
• 08809691368602: Endosseous dental implant abutment
• 08809691368374: Endosseous dental implant
• 08809691368367: Endosseous dental implant
• 08809691368350: Endosseous dental implant
• 08809691368329: Endosseous dental implant
• 08809691368312: Endosseous dental implant
• 08809691368305: Endosseous dental implant
• 08809691368275: Endosseous dental implant
• 08809691368268: Endosseous dental implant
• 08809691368251: Endosseous dental implant
• 08809691365786: Endosseous dental implant
• 08809691365779: Endosseous dental implant
• 08809691365748: Endosseous dental implant
• 08809691365731: Endosseous dental implant
• 08809691365724: Endosseous dental implant
• 08809691365694: Endosseous dental implant
• 08809691365687: Endosseous dental implant
• 08809691361122: Endosseous dental implant
• 08809691361115: Endosseous dental implant