ScrewIndirect® Implant Temporary Coping 4000-69
GUDID 10841307129981
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307129981 |
| NIH Device Record Key | 98dd2507-cba8-407c-832b-49285c150c16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ScrewIndirect® Implant Temporary Coping |
| 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 | |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307129981 [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 |
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
Moist Heat or Steam Sterilization
[10841307129981]
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 |
On-Brand Devices [ScrewIndirect® Implant Temporary Coping]
| 10841307114277 | 4000-69 |
| 10841307129981 | 4000-69 |
Trademark Results [ScrewIndirect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCREWINDIRECT 76628187 3330008 Live/Registered |
IMPLANT DIRECT SYBRON INTERNATIONAL LLC 2005-01-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.