| Primary Device ID | 10841307114239 |
| NIH Device Record Key | df7539b2-6f23-497b-9787-d5561b22f742 |
| Commercial Distribution Discontinuation | 2021-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Overdenture Comfort Cap (2 pieces) |
| Version Model Number | 4000-13 |
| Catalog Number | 4000-13 |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 2 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307114232 [Unit of Use] |
| GS1 | 10841307114239 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
[10841307114239]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-12-24 |
| Device Publish Date | 2015-09-14 |
| 10841307111627 - Legacy™ Plastic Engaging Temporary Abutment | 2024-12-23 |
| 10841307111634 - Legacy™ Plastic Engaging Temporary Abutment | 2024-12-23 |
| 10841307111641 - Legacy™ Plastic Engaging Temporary Abutment | 2024-12-23 |
| 10841307111696 - Legacy™ Plastic Temporary Abutment | 2024-12-23 |
| 10841307103585 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103592 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103608 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |
| 10841307103615 - ReActive® Implant | 2024-12-20 Ø3.7 x 8 Platform 3.5mmD |