Duo-Grip™ Extra Short Fixation Screw (2 pieces) 1000-20S
GUDID 10841307108832
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307108832 |
| NIH Device Record Key | 5a1a242e-a651-485a-b69c-7f76ea6ece1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duo-Grip™ Extra Short Fixation Screw (2 pieces) |
| Version Model Number | 1000-20S |
| Catalog Number | 1000-20S |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307108835 [Unit of Use] |
| GS1 | 10841307108832 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061319
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
Moist Heat or Steam Sterilization
[10841307108832]
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
| 10841307111627 - Legacy™ Plastic Engaging Temporary Abutment | 2024-12-23 |
| 10841307111634 - Legacy™ Plastic Engaging Temporary Abutment | 2024-12-23 |
| 10841307111641 - Legacy™ Plastic Engaging Temporary Abutment | 2024-12-23 |
| 10841307111696 - Legacy™ Plastic Temporary Abutment | 2024-12-23 |
| 10841307103585 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103592 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103608 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103615 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
Trademark Results [Duo-Grip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUO-GRIP 86814256 not registered Dead/Abandoned |
Marketing and Sales Management Corp. 2015-11-09 |
 DUO-GRIP 75015112 not registered Dead/Abandoned |
Chatwins Group, Inc. 1995-11-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.