Elos Accurate Pre-Milled Blank PMB-BCE60-1

GUDID 05712821013354

The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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 Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 05712821013354
• NIH Device Record Key: 13f1b456-ef69-48c6-aee6-4999e724b735
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Accurate Pre-Milled Blank
• Version Model Number: PMB-BCE60-1
• Catalog Number: PMB-BCE60-1
• Company DUNS: 306155953
• Company Name: Elos Medtech Pinol A/S
• Device Count: 1
• DM Exempt: false
• 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: 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	05712821013354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231307

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

[05712821013354]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [Elos Accurate Pre-Milled Blank]

• 05712821010605: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010599: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010582: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010575: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010568: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010551: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011411: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011404: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011398: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011381: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011374: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011367: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011350: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011343: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011312: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011305: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011299: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010322: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010315: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010308: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010292: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010285: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821010278: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011336: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821011329: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013538: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013521: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013514: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013408: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013392: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013385: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013378: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013361: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013354: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013347: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013330: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con
• 05712821013323: The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured con