| Primary Device ID | D990OTICMU5PKOA0 |
| NIH Device Record Key | b1821370-7bd4-491c-b46f-b2c18310598b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Open Tray Impression Coping Multi-Unit 5PK, Omnibut |
| Version Model Number | OTICMU5PK-OA |
| Company DUNS | 010613514 |
| Company Name | Smart Denture Conversions, LLC |
| 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 | 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 |
|---|---|
| HIBCC | D990OTICMU5PKOA0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
[D990OTICMU5PKOA0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-11 |
| Device Publish Date | 2024-11-01 |
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