IH Cement Abutment AIHCARH5540LD

GUDID 08800041322169

SEWON MEDIX IH Cement Abutment Regular Hex-Guide TiN-Coating Long Set Product, Ø5.5x4.0mm

sewon medix Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800041322169
• NIH Device Record Key: 012bc91e-0e53-4b4e-b4f7-e9c3c7980fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH Cement Abutment
• Version Model Number: AIHCARH5540LD
• Catalog Number: AIHCARH5540LD
• Company DUNS: 688731065
• Company Name: sewon medix Inc.
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800041322169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153521

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-21
• Device Publish Date: 2020-12-11

On-Brand Devices [IH Cement Abutment]

• 08800041320998: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø6.0x4.0mm
• 08800041320509: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Long Set Product, Ø5.0x2.0mm
• 08800041325405: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø6.0x4.0mm
• 08800041325368: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø6.0x2.0mm
• 08800041324958: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Long Set Product, Ø5.0x4.0mm
• 08800041324934: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Long Set Product, Ø5.0x3.0mm
• 08800041324910: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Long Set Product, Ø5.0x2.0mm
• 08800041324866: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø5.0x4.0mm
• 08800041324842: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø5.0x3.0mm
• 08800041324828: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø5.0x2.0mm
• 08800041324774: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Short Set Product, Ø5.0x4.0mm
• 08800041324750: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Short Set Product, Ø5.0x3.0mm
• 08800041324736: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Short Set Product, Ø5.0x2.0mm
• 08800041324590: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø4.5x4.0mm
• 08800041324576: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø4.5x3.0mm
• 08800041324552: SEWON MEDIX IH Cement Abutment Regular Hex Non-Coating Middle Set Product, Ø4.5x2.0mm
• 08800041324323: SEWON MEDIX IH Cement Abutment Mini Hex Non-Coating Middle Set Product, Ø4.5x4.0mm
• 08800041324309: SEWON MEDIX IH Cement Abutment Mini Hex Non-Coating Middle Set Product, Ø4.5x3.0mm
• 08800041324286: SEWON MEDIX IH Cement Abutment Mini Hex Non-Coating Middle Set Product, Ø4.5x2.0mm
• 08800041324262: SEWON MEDIX IH Cement Abutment Mini Hex Non-Coating Middle Set Product, Ø4.5x1.0mm
• 08800041321087: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Long Set Product, Ø6.0x4.0mm
• 08800041321063: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Long Set Product, Ø6.0x3.0mm
• 08800041321049: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Long Set Product, Ø6.0x2.0mm
• 08800041320974: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø6.0x3.0mm
• 08800041320950: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø6.0x2.0mm
• 08800041320936: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø6.0x1.0mm
• 08800041320882: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Short Set Product, Ø6.0x3.0mm
• 08800041320868: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Short Set Product, Ø6.0x2.0mm
• 08800041320844: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Short Set Product, Ø6.0x1.0mm
• 08800041320561: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Long Set Product, Ø5.0x5.0mm
• 08800041320547: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Long Set Product, Ø5.0x4.0mm
• 08800041320523: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Long Set Product, Ø5.0x3.0mm
• 08800041320455: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø5.0x4.0mm
• 08800041320431: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø5.0x3.0mm
• 08800041320417: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø5.0x2.0mm
• 08800041320363: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Short Set Product, Ø5.0x4.0mm
• 08800041320349: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Short Set Product, Ø5.0x3.0mm
• 08800041320325: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Short Set Product, Ø5.0x2.0mm
• 08800041320189: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø4.5x4.0mm
• 08800041320165: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø4.5x3.0mm
• 08800041320141: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø4.5x2.0mm
• 08800041319916: SEWON MEDIX IH Cement Abutment Mini Hex TiN-Coating Middle Set Product, Ø4.5x4.0mm
• 08800041319879: SEWON MEDIX IH Cement Abutment Mini Hex TiN-Coating Middle Set Product, Ø4.5x2.0mm
• 08800041319855: SEWON MEDIX IH Cement Abutment Mini Hex TiN-Coating Middle Set Product, Ø4.5x1.0mm
• 08800041324316: SEWON MEDIX IH Cement Abutment Mini Hex Non-Coating Middle Set Product, Ø4.5x3.5mm
• 08800041320127: SEWON MEDIX IH Cement Abutment Regular Hex TiN-Coating Middle Set Product, Ø4.5x1.0mm
• 08800041322169: SEWON MEDIX IH Cement Abutment Regular Hex-Guide TiN-Coating Long Set Product, Ø5.5x4.0mm
• 08800041322145: SEWON MEDIX IH Cement Abutment Regular Hex-Guide TiN-Coating Long Set Product, Ø5.5x3.0mm