DIRECTarch™ Direct to MUA Screw (10Pk) DA1000-DB
GUDID 00841307135213
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 00841307135213 |
| NIH Device Record Key | f0f0ec8a-a708-4c0e-89dd-b6562454a916 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIRECTarch™ Direct to MUA Screw (10Pk) |
| Version Model Number | DA1000-DB |
| Catalog Number | DA1000-DB |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 10 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307135213 [Unit of Use] |
| GS1 | 10841307135210 [Primary] |
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
[00841307135213]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-01 |
| Device Publish Date | 2025-04-23 |
Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC
| 10841307134855 - DIRECTarch™ Cylinder – 6.0mm | 2025-05-01 |
| 10841307135197 - DIRECTscan™ Adapter Kit - Empty | 2025-05-01 |
| 00841307135213 - DIRECTarch™ Direct to MUA Screw (10Pk) | 2025-05-01 |
| 00841307135213 - DIRECTarch™ Direct to MUA Screw (10Pk) | 2025-05-01 |
| 10841307132110 - SimplyIconic™ / InterActive™ SMARTbase, Extra Narrow, Non-Engaging | 2025-02-10 |
| 10841307132127 - DIRECTguide™ Sleeve Narrow | 2025-02-10 |
| 00841307128598 - DIRECTguide™ Sleeve Narrow (5PK) | 2025-02-10 |
| 10841307132141 - DIRECTguide™ Sleeve Regular | 2025-02-10 |
| 00841307128628 - DIRECTguide™ Sleeve Regular (5PK) | 2025-02-10 |
Trademark Results [DIRECTarch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIRECTARCH 98031874 not registered Live/Pending |
Implant Direct Sybron International LLC 2023-06-07 |
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