iphysio® Profile Designer SBLN_I.A3
GUDID 03700977501278
iphysio® Profile Designer Healing Abutment Size A3 and compatible screw
EUROTEKNIKA
Dental implant suprastructure, permanent, preformed| Primary Device ID | 03700977501278 |
| NIH Device Record Key | 95a279bb-9e28-4837-b050-ae37f46a73b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iphysio® Profile Designer |
| Version Model Number | SBLN_I.A3 |
| Catalog Number | SBLN_I.A3 |
| 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 | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 Millimeter |
| Height | 9.8 Millimeter |
| Length | 5.2 Millimeter |
| Width | 4.45 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 | 03700977501278 [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® Profile Designer]
| 03700977512540 | iphysio® Profile Designer Healing Abutment Size D3 and compatible screw |
| 03700977512533 | iphysio® Profile Designer Healing Abutment Size D1 and compatible screw |
| 03700977512526 | iphysio® Profile Designer Healing Abutment Size D4 and compatible screw |
| 03700977512519 | iphysio® Profile Designer Healing Abutment Size D2 and compatible screw |
| 03700977512502 | iphysio® Profile Designer Healing Abutment Size D4 and compatible screw |
| 03700977512496 | iphysio® Profile Designer Healing Abutment Size D3 and compatible screw |
| 03700977512489 | iphysio® Profile Designer Healing Abutment Size D2 and compatible screw |
| 03700977512472 | iphysio® Profile Designer Healing Abutment Size D1 and compatible screw |
| 03700977512465 | iphysio® Profile Designer Healing Abutment Size D3 and compatible screw |
| 03700977512458 | iphysio® Profile Designer Healing Abutment Size D1 and compatible screw |
| 03700977511505 | iphysio® Profile Designer Healing Abutment Size A2 and compatible screw |
| 03700977511499 | iphysio® Profile Designer Healing Abutment Size A4 and compatible screw |
| 03700977511482 | iphysio® Profile Designer Healing Abutment Size B2 and compatible screw |
| 03700977511451 | iphysio® Profile Designer Healing Abutment Size D2 and compatible screw |
| 03700977511444 | iphysio® Profile Designer Healing Abutment Size D3 and compatible screw |
| 03700977511437 | iphysio® Profile Designer Healing Abutment Size D4 and compatible screw |
| 03700977511420 | iphysio® Profile Designer Healing Abutment Size B2 and compatible screw |
| 03700977511413 | iphysio® Profile Designer Healing Abutment Size B4 and compatible screw |
| 03700977511406 | iphysio® Profile Designer Healing Abutment Size C2 and compatible screw |
| 03700977511390 | iphysio® Profile Designer Healing Abutment Size C4 and compatible screw |
| 03700977511383 | iphysio® Profile Designer Healing Abutment Size D1 and compatible screw |
| 03700977511376 | iphysio® Profile Designer Healing Abutment Size D2 and compatible screw |
| 03700977511369 | iphysio® Profile Designer Healing Abutment Size D3 and compatible screw |
| 03700977511352 | iphysio® Profile Designer Healing Abutment Size D4 and compatible screw |
| 03700977511246 | iphysio® Profile Designer Healing Abutment Size A2 and compatible screw |
| 03700977511239 | iphysio® Profile Designer Healing Abutment Size A4 and compatible screw |
| 03700977511222 | iphysio® Profile Designer Healing Abutment Size B2 and compatible screw |
| 03700977511215 | iphysio® Profile Designer Healing Abutment Size B4 and compatible screw |
| 03700977511208 | iphysio® Profile Designer Healing Abutment Size D2 and compatible screw |
| 03700977511192 | iphysio® Profile Designer Healing Abutment Size D4 and compatible screw |
| 03700977511185 | iphysio® Profile Designer Healing Abutment Size B2 and compatible screw |
| 03700977511178 | iphysio® Profile Designer Healing Abutment Size B4 and compatible screw |
| 03700977511161 | iphysio® Profile Designer Healing Abutment Size C2 and compatible screw |
| 03700977511154 | iphysio® Profile Designer Healing Abutment Size C4 and compatible screw |
| 03700977511147 | iphysio® Profile Designer Healing Abutment Size A2 and compatible screw |
| 03700977511130 | iphysio® Profile Designer Healing Abutment Size A4 and compatible screw |
| 03700977511123 | iphysio® Profile Designer Healing Abutment Size B2 and compatible screw |
| 03700977511116 | iphysio® Profile Designer Healing Abutment Size B4 and compatible screw |
| 03700977511109 | iphysio® Profile Designer Healing Abutment Size C2 and compatible screw |
| 03700977511093 | iphysio® Profile Designer Healing Abutment Size C4 and compatible screw |
| 03700977511086 | iphysio® Profile Designer Healing Abutment Size D1 and compatible screw |
| 03700977511079 | iphysio® Profile Designer Healing Abutment Size D2 and compatible screw |
| 03700977511062 | iphysio® Profile Designer Healing Abutment Size D3 and compatible screw |
| 03700977511055 | iphysio® Profile Designer Healing Abutment Size D4 and compatible screw |
| 03700977511048 | iphysio® Profile Designer Healing Abutment Size B2 and compatible screw |
| 03700977511031 | iphysio® Profile Designer Healing Abutment Size B4 and compatible screw |
| 03700977510881 | iphysio® Profile Designer Healing Abutment Size C2 and compatible screw |
| 03700977510874 | iphysio® Profile Designer Healing Abutment Size C4 and compatible screw |
| 03700977505467 | iphysio® Profile Designer Healing Abutment Size A1 and compatible screw |
| 03700977505450 | iphysio® Profile Designer Healing Abutment Size A3 and compatible screw |
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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