GoDirect® Implant Comfort Cap 4500-26
GUDID 00841307129809
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, temporary, preformed, single-use| Primary Device ID | 00841307129809 |
| NIH Device Record Key | 0ca705d5-85f9-4e85-95a1-e8be97f0650c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GoDirect® Implant Comfort Cap |
| Version Model Number | 4500-26 |
| Catalog Number | 4500-26 |
| 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 | 00841307129809 [Unit of Use] |
| GS1 | 10841307129806 [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 |
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
Moist Heat or Steam Sterilization
[00841307129809]
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 [GoDirect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GODIRECT 88213357 5793539 Live/Registered |
Associates for the Advancement of Musculoskeletal Innovation, Inc. 2018-12-01 |
 GODIRECT 87326482 5295254 Live/Registered |
Honeywell International Inc. 2017-02-07 |
 GODIRECT 86825571 5247109 Live/Registered |
Honeywell International Inc. 2015-11-19 |
 GODIRECT 86664931 4931272 Live/Registered |
Plavan Commercial Fueling, Inc. 2015-06-17 |
 GODIRECT 86014421 not registered Dead/Abandoned |
CORE ORTHOPAEDICS, INC. 2013-07-18 |
 GODIRECT 85395850 4141754 Live/Registered |
Implant Direct Sybron International LLC 2011-08-11 |
 GODIRECT 77961974 3972491 Dead/Cancelled |
eWinWin, Inc. 2010-03-18 |
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