InterActive® Overdenture Abutment Narrow 6534-64N
GUDID 10841307110064
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 10841307110064 |
| NIH Device Record Key | 41abd7ae-10a9-42a7-85e3-ae32e6e62dd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InterActive® Overdenture Abutment Narrow |
| Version Model Number | 6534-64N |
| Catalog Number | 6534-64N |
| 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 | 10841307110064 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130572
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
Moist Heat or Steam Sterilization
[10841307110064]
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 [InterActive® Overdenture Abutment Narrow]
| 10841307110071 | 6534-65N |
| 10841307110064 | 6534-64N |
| 10841307110057 | 6534-63N |
| 10841307110040 | 6534-62N |
| 10841307110033 | 6534-61N |
| 10841307129820 | 6534-63N |
Trademark Results [InterActive]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.