iphysio® NCCN_I.D1
GUDID 03700977511468
iphysio® Profile Designer Healing Abutment Size D1 and compatible screw
EUROTEKNIKA
Dental implant suprastructure, permanent, preformed| Primary Device ID | 03700977511468 |
| NIH Device Record Key | ff59396e-9197-4c0e-8506-074533685658 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iphysio® |
| Version Model Number | NCCN_I.D1 |
| Catalog Number | NCCN_I.D1 |
| Company DUNS | 382690691 |
| Company Name | EUROTEKNIKA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Device Dimensions
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
| Height | 7.78 Millimeter |
| Length | 6.1 Millimeter |
| Width | 4.8 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700977511468 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232383
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 | 2025-06-02 |
| Device Publish Date | 2025-05-23 |
On-Brand Devices [iphysio®]
| 03700977511888 | Universal Try-in Abutment Size A2 |
| 03700977511871 | Universal Try-in Abutment Size A4 |
| 03700977511857 | Universal Try-in Abutment Size B2 |
| 03700977511840 | Universal Try-in Abutment Size B4 |
| 03700977511826 | Universal Try-in Abutment Size C2 |
| 03700977511819 | Universal Try-in Abutment Size C4 |
| 03700977511796 | Universal Try-in Abutment Size D1 |
| 03700977511789 | Universal Try-in Abutment Size D2 |
| 03700977511772 | Universal Try-in Abutment Size D3 |
| 03700977511765 | Universal Try-in Abutment Size D4 |
| 03700977511475 | iphysio® Profile Designer Healing Abutment Size B4 and compatible screw |
| 03700977511468 | iphysio® Profile Designer Healing Abutment Size D1 and compatible screw |
| 03700977511345 | Temporary Abutment and screw for NCCR iphysio |
| 03700977506402 | Universal Try-in Abutment Size A1 |
| 03700977506396 | Universal Try-in Abutment Size A3 |
| 03700977506389 | Universal Try-in Abutment Size B1 |
| 03700977506372 | Universal Try-in Abutment Size B3 |
| 03700977506365 | Universal Try-in Abutment Size C1 |
| 03700977506358 | Universal Try-in Abutment Size C3 |
| 03700977505504 | Universal Try-in Abutment Kit |
| 03700977505436 | iphysio® Profile Designer Healing Abutment Size B3 and compatible screw |
| 03700977505429 | Temporary Abutment and screw for NCCN iphysio |
| 03700977501292 | Temporary Abutment and screw for SBL iphysio |
| 03700977500103 | Temporary Abutment and screw for ZSC iphysio |
Trademark Results [iphysio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IPHYSIO 79388707 not registered Live/Pending |
EUROTEKNIKA 2023-11-21 |
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