Biodenta I-BA60B2L10A

GUDID 07640169732546

Dental Implant / Bone Level / Ø 6.0 / B2 / L10

Biodenta Swiss AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07640169732546
• NIH Device Record Key: b39b703a-ab46-4ef2-b05c-d6b4d7922c40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biodenta
• Version Model Number: I-BA60B2L10A
• Catalog Number: I-BA60B2L10A
• Company DUNS: 484609081
• Company Name: Biodenta Swiss AG
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640169732546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123512

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Biodenta]

• 07640169739927: Biodenta Customized Abutment - Hybrid
• 07640169739910: Biodenta Customized Abutment - Titanium
• 07640169734076: Bar Abutment with Screw – Titanium Alloy / B2 / can be shortened / BL & TP
• 07640169734069: Bar Abutment with Screw – Titanium Alloy / B1 / can be shortened / BL & TP
• 07640169734021: Ball Abutment / B2 / GH 6.0 / BL & TP
• 07640169734014: Ball Abutment / B2 / GH 4.0 / BL & TP
• 07640169734007: Ball Abutment / B2 / GH 2.0 / BL & TP
• 07640169733994: Ball Abutment / B1 / GH 6.0 / BL & TP
• 07640169733987: Ball Abutment / B1 / GH 4.0 / BL & TP
• 07640169733970: Ball Abutment / B1 / GH 2.0 / BL & TP
• 07640169733963: Ball Abutment / B0 / GH 6.0 / BL & TP
• 07640169733956: Ball Abutment / B0 / GH 4.0 / BL & TP
• 07640169733949: Ball Abutment / B0 / GH 2.0 / BL & TP
• 07640169733932: Locator® Abutment / B2 / GH 6.0 / BL & TP
• 07640169733925: Locator® Abutment / B2 / GH 4.0 / BL & TP
• 07640169733918: Locator® Abutment / B2 / GH 2.0 / BL & TP
• 07640169733901: Locator® Abutment / B1 / GH 6.0 / BL & TP
• 07640169733895: Locator® Abutment / B1 / GH 4.0 / BL & TP
• 07640169733888: Locator® Abutment / B1 / GH 2.0 / BL & TP
• 07640169733871: Locator® Abutment / B0 / GH 6.0 / BL & TP
• 07640169733864: Locator® Abutment / B0 / GH 4.0 / BL & TP
• 07640169733857: Locator® Abutment / B0 / GH 2.0 / BL & TP
• 07640169733840: Gold Abutment with Screw for Bridge / B2 / BL & TP
• 07640169733833: Gold Abutment with Screw for Bridge / B1 / BL & TP
• 07640169733826: Gold Abutment with Screw for Crown / B2 / BL & TP
• 07640169733819: Gold Abutment with Screw for Crown / B1 / BL & TP
• 07640169733802: Temporary Abutment Screw (PEEK) / B2 / BL & TP
• 07640169733796: Temporary Abutment Screw (PEEK) / B1 / BL & TP
• 07640169733789: Temporary Abutment (PEEK) with Screw / B2 / D 6.5 / plastic / BL & TP
• 07640169733772: Temporary Abutment (PEEK) with Screw / B1 / D 6.5 / plastic / BL & TP
• 07640169733765: Temporary Abutment (PEEK) with Screw / B2 / D 4.0 / plastic / BL & TP
• 07640169733758: Temporary Abutment (PEEK) with Screw / B1 / D 4.0 / plastic / BL & TP
• 07640169733741: Temporary Abutment with Screw for Crown / B2 / BL & TP
• 07640169733734: Temporary Abutment with Screw for Crown / B1 / BL & TP
• 07640169733727: Temporary Abutment with Screw for Crown / B0 / BL & TP
• 07640169733710: Temporary Abutment with Screw for Bridge / B2 / BL & TP
• 07640169733703: Temporary Abutment with Screw for Bridge / B1 / BL & TP
• 07640169733697: Temporary Abutment with Screw for Bridge / B0 / BL & TP
• 07640169732553: Dental Implant / Bone Level / Ø 6.0 / B2 / L12
• 07640169732546: Dental Implant / Bone Level / Ø 6.0 / B2 / L10
• 07640169732539: Dental Implant / Bone Level / Ø 6.0 / B2 / L08
• 07640169732522: Dental Implant / Bone Level / Ø 6.0 / B2 / L6.5
• 07640169732515: Dental Implant / Bone Level / Ø 4.8 / B2 / L14
• 07640169732508: Dental Implant / Bone Level / Ø 4.8 / B2 / L12
• 07640169732492: Dental Implant / Bone Level / Ø 4.8 / B2 / L10
• 07640169732485: Dental Implant / Bone Level / Ø 4.8 / B2 / L08
• 07640169732478: Dental Implant / Bone Level / Ø 4.8 / B2 / L6.5
• 07640169732461: Dental Implant / Bone Level / Ø 4.1 / B2 / L14
• 07640169732454: Dental Implant / Bone Level / Ø 4.1 / B2 / L12
• 07640169732447: Dental Implant / Bone Level / Ø 4.1 / B2 / L10