Legacy™ Overdenture Abutment 8035-62
GUDID 10841307111498
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307111498 |
| NIH Device Record Key | 5afe3fb8-4b6b-4f15-b577-2d7bc3fad46a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Legacy™ Overdenture Abutment |
| Version Model Number | 8035-62 |
| Catalog Number | 8035-62 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841307111498 [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 |
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
Moist Heat or Steam Sterilization
[10841307111498]
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 [Legacy™ Overdenture Abutment]
| 10841307111610 | 8530-65 |
| 10841307111603 | 8530-64 |
| 10841307111597 | 8530-63 |
| 10841307111580 | 8530-62 |
| 10841307111573 | 8530-61 |
| 10841307111566 | 8057-64 |
| 10841307111559 | 8057-62 |
| 10841307111542 | 8057-61 |
| 10841307111535 | 8045-64 |
| 10841307111528 | 8045-62 |
| 10841307111511 | 8045-61 |
| 10841307111504 | 8035-64 |
| 10841307111498 | 8035-62 |
| 10841307111481 | 8035-61 |
Trademark Results [Legacy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEGACY 98863704 not registered Live/Pending |
Coach IP Holdings LLC 2024-11-20 |
 LEGACY 98807417 not registered Live/Pending |
First Gear, Inc. 2024-10-17 |
 LEGACY 98694725 not registered Live/Pending |
Digital Mining, LLC 2024-08-12 |
 LEGACY 98643255 not registered Live/Pending |
ACC Crappie Stix, LLC 2024-07-11 |
 LEGACY 98565038 not registered Live/Pending |
Double Dragon International Inc. 2024-05-23 |
 LEGACY 98480672 not registered Live/Pending |
Sony Music Entertainment 2024-04-02 |
 LEGACY 98065035 not registered Live/Pending |
Legacy Pickleball, LLC 2023-06-29 |
 LEGACY 97876480 not registered Live/Pending |
Legacy Publishing Group, Inc. 2023-04-06 |
 LEGACY 97873756 not registered Live/Pending |
All Services Management, LLC 2023-04-05 |
 LEGACY 97867232 not registered Live/Pending |
Levendi, LLC 2023-03-31 |
 LEGACY 97820146 not registered Live/Pending |
Majano, Rameses 2023-03-02 |
LEGACY 97820146 not registered Live/Pending |
Ardon, Jackelin 2023-03-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.