CERALOG® PL Bonding base bridge, Ø 3.8 mm, GH 0.8 mm HP2247.3808

GUDID 07640161396555

CERALOG® PL Bonding base bridge, Ø 3.8 mm, GH 0.8 mm

Dentalpoint AG

Dental implant suprastructure kit

• Primary Device ID: 07640161396555
• NIH Device Record Key: d718f51e-c284-4219-afa5-5e0d148f88f1
• Commercial Distribution Discontinuation: 2024-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CERALOG® PL Bonding base bridge, Ø 3.8 mm, GH 0.8 mm
• Version Model Number: HP2247.3808
• Catalog Number: HP2247.3808
• Company DUNS: 483229493
• Company Name: Dentalpoint 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: 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

Customer Support Contacts

• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de
• Phone: +41443883636
• Email: mpd.regulatory@ceramtec.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161396555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163043

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

[07640161396555]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-07
• Device Publish Date: 2024-04-29

Devices Manufactured by Dentalpoint AG

• 07640161393769 - ZERAMEX®XT Rescue-Shell XT REGULAR: 2024-05-15 ZERAMEX®XT Rescue-Shell XT REGULAR
• 07640161393776 - ZERAMEX®XT Rescue-Shell XT WIDE: 2024-05-15 ZERAMEX®XT Rescue-Shell XT WIDE
• 07640161395077 - ZERAMEX®XT Rescue-Shell XT SMALL: 2024-05-15 ZERAMEX®XT Rescue-Shell XT SMALL
• 07640161396401 - CERALOG PL Implant, Ø 3.8 L 9: 2024-05-07 Dental Implant
• 07640161396432 - CERALOG PL Implant, Ø 3.8 L 11: 2024-05-07 Dental Implant
• 07640161396449 - CERALOG PL Implant, Ø 3.8 L 13: 2024-05-07 Dental Implant
• 07640161396456 - CERALOG PL Implant, Ø 4.3 L 9: 2024-05-07 Dental Implant
• 07640161396463 - CERALOG PL Implant,Ø 4.3 L 11: 2024-05-07 Dental Implant