NobelPearl Tapered NP 3.5x12mm 300754

GUDID 07640161394346

Dental Implant

Dentalpoint AG

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: 07640161394346
• NIH Device Record Key: 229682ea-4359-4d3c-a7a4-249a40decfe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelPearl Tapered NP 3.5x12mm
• Version Model Number: 300754
• Catalog Number: 300754
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

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
• 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
• 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	07640161394346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180184

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-03
• Device Publish Date: 2021-10-26

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