RePlant® Angled Multi-Unit Abutment 6043-64-15
GUDID 10841307126805
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307126805 |
| NIH Device Record Key | 28a0a246-0e0f-4eec-a81e-d3872d5c571c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RePlant® Angled Multi-Unit Abutment |
| Version Model Number | 6043-64-15 |
| Catalog Number | 6043-64-15 |
| 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 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 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307126805 [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 |
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
[10841307126805]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-20 |
| Device Publish Date | 2021-04-12 |
On-Brand Devices [RePlant® Angled Multi-Unit Abutment]
| 10841307126836 | 6050-64-30 |
| 10841307126829 | 6050-64-15 |
| 10841307126812 | 6043-64-30 |
| 10841307126805 | 6043-64-15 |
| 10841307126799 | 6035-64-30 |
| 10841307126782 | 6035-64-15 |
Trademark Results [RePlant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REPLANT 97914673 not registered Live/Pending |
Von Holzhausen 2023-05-01 |
 REPLANT 97914671 not registered Live/Pending |
Von Holzhausen 2023-05-01 |
 REPLANT 97036376 not registered Live/Pending |
Strange Attractor, LLC 2021-09-20 |
 REPLANT 88518101 not registered Live/Pending |
Michelle MacRae 2019-07-17 |
 REPLANT 77097406 not registered Dead/Abandoned |
Implant Direct LLC 2007-02-01 |
 REPLANT 76628186 3344697 Live/Registered |
IMPLANT DIRECT SYBRON INTERNATIONAL LLC 2005-01-19 |
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