CERALOG® PL Temp. abut. screw L 8.6 mm HP4041.2000

GUDID 07640161396814

Prosthetics

Dentalpoint AG

Dental implant system

• Primary Device ID: 07640161396814
• NIH Device Record Key: 2785fdd1-73bb-46e5-bf91-c24bc3c51a2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERALOG® PL Temp. abut. screw L 8.6 mm
• Version Model Number: HP4041.2000
• Catalog Number: HP4041.2000
• Company DUNS: 483229493
• Company Name: Dentalpoint AG
• Device Count: 1
• DM Exempt: true
• 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: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com
• Phone: +41443883630
• Email: pascal.wettstein@zeramex.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161396814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180184

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

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

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