| Primary Device ID | D894SK200 |
| NIH Device Record Key | aed30f73-0561-4d7c-ad69-967c120a22b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PiezoImplant System |
| Version Model Number | BL MUA Driver |
| Catalog Number | SK-20 |
| Company DUNS | 080746478 |
| Company Name | Rex Implants, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com | |
| Phone | 614-304-3021 |
| info@reximplants.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D894SK200 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
[D894SK200]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-25 |
| Device Publish Date | 2024-06-17 |
| D894R4530 | Custom Abutment Blank BL 2.9 |
| D894R2380 | Custom Abutment Blank TL 2.9 |
| D894R1380 | Custom Abutment Blank TL 1.8 |
| D894R4030 | Adapter - BL 2.9 to External Hexagon (TL 1.8) H4 |
| D894R4020 | Adapter - BL 2.9 to External Hexagon (TL 1.8) H3 |
| D894R4010 | Adapter - BL 2.9 to External Hexagon (TL 1.8) H2 |
| D894R4400 | MUA Ti Base R BL 2.9 |
| D894R1450 | MUA Angled Channel Coping Screw TL 1.8 / 2.9 |
| D894R1440 | MUA Digital Lab Analog TL 1.8 / 2.9 |
| D894R1430 | MUA Scan Body TL 1.8 / 2.9 |
| D894R1330 | Digital Lab Analog TL 1.8 |
| D894R1320 | MUA Ti Base TL 1.8 / 2.9 |
| D894R1290 | Scan Body TL 1.8 |
| D894SK380 | Angled Channel Driver, L (1.6 mm Hex) |
| D894SK370 | Angled Channel Driver, S (1.6 mm Hex) |
| D894SK270 | Removal Carrier BL 2.9 |
| D894SK200 | BL MUA Driver |
| D894R4660 | MUA Digital Lab Analog BL 2.9 |
| D894R4650 | MUA Angled Channel Coping Screw BL 2.9 |
| D894R4640 | MUA Ti Base AR BL 2.9 |
| D894R4630 | MUA Scan Body BL 2.9 |
| D894R4520 | Digital Lab Analog BL 2.9 |
| D894R4490 | Scan Body BL 2.9 |
| D894R2330 | Scan Body TL 2.9 |