Duo-Grip™ Fixation Screw Extra Short 1000-19S
GUDID 00841307129595
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 00841307129595 |
| NIH Device Record Key | 81aed2be-7010-44a7-9960-2618e409349a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duo-Grip™ Fixation Screw Extra Short |
| Version Model Number | 1000-19S |
| Catalog Number | 1000-19S |
| 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 | |
| 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 | |
| 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 | 00841307129595 [Unit of Use] |
| GS1 | 10841307129592 [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 |
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
[00841307129595]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
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 |
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