ScrewIndirect® Implant Titanium Cylinder 4000-69
GUDID 10841307126966
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307126966 |
| NIH Device Record Key | aa450d5d-a852-44f8-b5af-17f6defed30f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ScrewIndirect® Implant Titanium Cylinder |
| Version Model Number | 4000-69 |
| Catalog Number | 4000-69 |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com | |
| Phone | 1-888-649-6425 |
| customerservice@implantdirect.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307126966 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081101
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
[10841307126966]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-20 |
| Device Publish Date | 2021-04-12 |
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 [ScrewIndirect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCREWINDIRECT 76628187 3330008 Live/Registered |
IMPLANT DIRECT SYBRON INTERNATIONAL LLC 2005-01-19 |
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