| Primary Device ID | 08059224144344 |
| NIH Device Record Key | 3165bf81-e93b-4a25-a4c3-1d56ef4dd5eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OT EQUATOR TITANIUM ABUTMENT |
| Version Model Number | Equator Tri-Nex ø4.3 x 5mm Kit |
| Catalog Number | Z-EQ-131TN435 |
| Company DUNS | 439240722 |
| Company Name | RHEIN 83 SRL |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08059224144344 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
[08059224144344]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2024-11-12 |
| D821OTEQUATOR30CV576 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO7 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO6 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO5 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO4 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO3 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO2 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO1 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SWO05 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL57 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL56 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL55 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL54 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL53 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL52 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL47 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL46 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL45 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL43 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL42 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL3257 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL3256 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL3255 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL3254 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL3253 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030SPL3252 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS57 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS56 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS55 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS54 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS53 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS52 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS51 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS505 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS437 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS436 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS435 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS434 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS433 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS432 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS431 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS4305 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS357 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS356 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS355 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS354 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS353 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS352 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS351 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |
| D821OTEQUATOR030RPS3505 | The OT Equator is designed as an endosseous dental implant retentive component used to retain a |