Abutment Blank

GUDID 05712821003034

The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by an Elos Medtech approved milling facility. The customized abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

Elos Medtech Pinol A/S

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 05712821003034
• NIH Device Record Key: e340dd97-b092-4458-b93d-a643eba178e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abutment Blank
• Version Model Number: AB-SBO331213
• Company DUNS: 306155953
• Company Name: Elos Medtech Pinol A/S
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05712821003034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190299

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05712821003034]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-13
• Device Publish Date: 2019-11-05

On-Brand Devices [Abutment Blank]

• 05712821003058: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821003034: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821003010: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002990: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002976: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002952: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002938: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002914: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002891: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002877: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002679: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002655: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002594: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002518: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002495: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002464: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002440: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002426: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002402: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821009609: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821009586: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821009562: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821003157: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821003133: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821003119: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821003096: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821003072: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002570: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002556: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002532: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821011251: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002471: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne
• 05712821002389: The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured conne