| Primary Device ID | 00810004900615 |
| NIH Device Record Key | de35174b-b563-4042-b43a-cd0b29e37234 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | YomiLink Teeth Posterior (LLUR) |
| Version Model Number | DRW-2081-01 |
| Company DUNS | 802312434 |
| Company Name | NEOCIS INC |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810004900615 [Primary] |
| PLV | Dental Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
[00810004900615]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-27 |
| Device Publish Date | 2024-05-17 |
| 00810004900622 - Neocis Guidance System | 2025-05-12 Instrumentarium OP 300 Chin Rest-DRW-0735-12 |
| 00810004900394 - Neocis Guidance System | 2024-07-29 TrackerNeo Draping Kit |
| 00810004900608 - YomiLink Teeth Posterior (LRUL) | 2024-05-27 YomiLink Teeth Posterior (LRUL) |
| 00810004900615 - YomiLink Teeth Posterior (LLUR) | 2024-05-27YomiLink Teeth Posterior (LLUR) |
| 00810004900615 - YomiLink Teeth Posterior (LLUR) | 2024-05-27 YomiLink Teeth Posterior (LLUR) |
| 00810004900523 - YomiLink Arch (LLUR) | 2023-08-24 YomiLink Arch (LLUR) |
| 00810004900530 - YomiLink Arch (LRUL) | 2023-08-24 YomiLink Arch (LRUL) |
| 00810004900547 - YLA Probing Bit - Contra Angle | 2023-08-24 YLA Probing Bit - Contra Angle |
| 00810004900554 - YLA Probing Bit - Straight | 2023-08-24 YLA Probing Bit - Straight |