ScrewIndirect® Implant Temporary Coping 4000-69
GUDID 10841307114277
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307114277 |
| NIH Device Record Key | 6cedf051-1fcc-4941-b87a-fe389b6f3313 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307114277 [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 |
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
Moist Heat or Steam Sterilization
[10841307114277]
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 |
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 |
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