ZERAMEX® XT Implant Ø4.2x14mm RB (incl. Healing Ca XT16514
GUDID 07640161391833
Dental Implant
Dentalpoint AG
Dental implant system| Primary Device ID | 07640161391833 |
| NIH Device Record Key | 1e42688a-a402-452c-9283-4541932071d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZERAMEX® XT Implant Ø4.2x14mm RB (incl. Healing Ca |
| Version Model Number | XT16514 |
| Catalog Number | XT16514 |
| 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
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com | |
| Phone | +41443883630 |
| pascal.wettstein@zeramex.com |
Operating and Storage Conditions
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640161391833 [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 | 2018-12-31 |
| Device Publish Date | 2018-11-30 |
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 |
Trademark Results [ZERAMEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZERAMEX 79184529 5093433 Live/Registered |
Dentalpoint AG 2015-12-09 |
 ZERAMEX 77522688 4522136 Live/Registered |
Dentalpoint AG 2008-07-15 |
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