SwishPlant® Fixation Screw (2 pieces) 1000-17
GUDID 10841307108757
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307108757 |
| NIH Device Record Key | cd56f937-385d-4d9f-b072-7907928fb498 |
| Commercial Distribution Discontinuation | 2016-08-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SwishPlant® Fixation Screw (2 pieces) |
| Version Model Number | 1000-17 |
| Catalog Number | 1000-17 |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 2 |
| DM Exempt | false |
| 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 | false |
| Expiration Date | false |
| 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 | 1-888-649-6425 |
| customerservice@implantdirect.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307108750 [Unit of Use] |
| GS1 | 10841307108757 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090234
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307108757]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-09-14 |
Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC
| 00841307129519 - Long Fixation Screw | 2024-03-20 |
| 00841307129526 - Dual-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129533 - Dual-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129540 - Long Fixation Screw | 2024-03-20 |
| 00841307129557 - Fixation Screw | 2024-03-20 |
| 00841307129571 - Duo-Grip™ Long Fixation Screw | 2024-03-20 |
| 00841307129588 - Duo-Grip™ Fixation Screw | 2024-03-20 |
| 00841307129595 - Duo-Grip™ Fixation Screw Extra Short | 2024-03-20 |
Trademark Results [SwishPlant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SWISHPLANT 85303490 4246746 Dead/Cancelled |
Implant Direct Sybron International LLC 2011-04-25 |
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