| Primary Device ID | D798SMCLB0 |
| NIH Device Record Key | 186a011f-53f0-4ec1-8756-3f7dd094f6d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crown Lok |
| Version Model Number | SMCLB |
| Catalog Number | SMCLB |
| Company DUNS | 113170088 |
| Company Name | RELIANCE ORTHODONTIC PRODUCTS 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 630-773-4009 |
| paulgropi@aol.com | |
| Phone | 630-773-4009 |
| paulgropi@aol.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (15-30 Degrees C |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (15-30 Degrees C |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D798SMCLB0 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-10-29 |
| Device Publish Date | 2016-07-27 |
| D798SMCLBK0 | Crown Lok is intended for use as a cement for metal crowns and orthodontic bands. This is the S |
| D798SMCLB0 | Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is th |
| D7981SMCLB0 | Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is th |