TitaniumBase EV ASA (S) 4mm NI 68012577

GUDID 05712821014368

The TitaniumBase EV ASA is a two-piece abutment which is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The TitaniumBase EV ASA is available in an indexed variant for single unit restorations and a non-indexed variant for multi-unit restorations. The TitaniumBase EV ASA is available in different gingival heights. The TitaniumBase EV ASA has a chimney height of 7.5 mm which can be shortened as far as 3.5 mm at predefined grooves. TitaniumBase EV ASA size XS is limited to replacement of maxillary lateral incisors and mandibular incisors.

Elos Medtech Pinol A/S

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 05712821014368
• NIH Device Record Key: 6213b1f2-fead-4eb4-bf4a-6d2a86fe37c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TitaniumBase EV ASA (S) 4mm NI
• Version Model Number: 68012577
• Catalog Number: 68012577
• 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	05712821014368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242025

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

[05712821014368]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

Devices Manufactured by Elos Medtech Pinol A/S

• 05712821012876 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012920 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012937 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012944 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012951 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012968 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012975 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012982 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa