NobelPearl™ Healing Abutment Inter-X NP 3.5x4mm 300705
GUDID 07640161394643
Prosthetics
Dentalpoint AG
Dental implant suprastructure, temporary, preformed, single-use| Primary Device ID | 07640161394643 |
| NIH Device Record Key | 943e1046-77bb-4302-bfd7-5c7143e57b06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelPearl™ Healing Abutment Inter-X NP 3.5x4mm |
| Version Model Number | 300705 |
| Catalog Number | 300705 |
| 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 | 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
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 |
| 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 | 07640161394643 [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 | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-21 |
| Device Publish Date | 2022-01-13 |
Devices Manufactured by Dentalpoint AG
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| 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 |
Trademark Results [NobelPearl]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELPEARL 79239914 not registered Live/Pending |
Nobel Biocare Services AG 2018-05-30 |
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