| Primary Device ID | D785OTYELLOW40 |
| NIH Device Record Key | 290f7ffc-bb03-4d1d-a50a-a44b1ec82148 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4 PACK OT EQUATOR YELLOW INSERT |
| Version Model Number | OT YELLOW 4 |
| Catalog Number | OT YELLOW 4 |
| Company DUNS | 094146123 |
| Company Name | OCO BIOMEDICAL 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D785OTYELLOW40 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-12 |
| Device Publish Date | 2026-02-04 |
| D785OTCAP100 - 10 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT | 2026-02-12 10 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT |
| D785OTCAP40 - 4 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT | 2026-02-12 4 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT |
| D785OTPINK40 - 4 PACK OT EQUATOR PINK INSERTS | 2026-02-12 4 PACK OT EQUATOR PINK INSERTS |
| D785OTPU20 - 2 PACK OT EQUATOR IMPRESSION COPING | 2026-02-12 2 PACK OT EQUATOR IMPRESSION COPING |
| D785OTYELLOW40 - 4 PACK OT EQUATOR YELLOW INSERT | 2026-02-124 PACK OT EQUATOR YELLOW INSERT |
| D785OTYELLOW40 - 4 PACK OT EQUATOR YELLOW INSERT | 2026-02-12 4 PACK OT EQUATOR YELLOW INSERT |
| D78589490 - TSI/ERI Locator Abutment | 2025-09-11 Overdenture Abutment 0mm, 4.0 mm Diameter, 0mm height |
| D7850330T0 - Osteotomy Former | 2024-12-11 3.3mm Osteotomy Former 3.3mm Diameter For placement of the 3.6mm Engage Implant (Lower) |
| D7853610ENGAGE0 - Two Stage Bone Level Dental Implant | 2024-12-11 Two Stage Bone Level Dental Implant: 3.6mm Diameter X 10mm Length |