| Primary Device ID | D952CM0011 |
| NIH Device Record Key | e7aec21f-f370-477f-9185-a419c3407689 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LayZir Disc |
| Version Model Number | CM0011S |
| Catalog Number | CM0011S |
| Company DUNS | 112861098 |
| Company Name | SMART DENTISTRY SOLUTIONS 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 | false |
| OTC Over-The-Counter | false |
| Phone | 9494469383 |
| Info@SmartDentistrySolutions.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D952CM0011 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-25 |
| Device Publish Date | 2020-06-17 |
| D952CM0036 | LayZir Disc AD98-25-LZ B1 |
| D952CM0035 | LayZir Disc AD98-25-LZ A3 |
| D952CM0034 | LayZir isc AD98-25-LZ A2 |
| D952CM0033 | LayZir Disc AD98-25-LZ A1 |
| D952CM0032 | LayZir Disc AD98-25-LZ BL2 |
| D952CM0031 | LayZir Disc AD98-25-LZ-BL1 |
| D952CM0030 | LayZir Disc AD98-22-LZ B1 |
| D952CM0029 | LayZir Disc AD98-22-LZ A3 |
| D952CM0028 | LayZir Disc AD98-22-LZ A2 |
| D952CM0027 | LayZir Disc AD98-22-LZ A1 |
| D952CM0026 | LayZir Disc AD98-22-LZ-BL2 |
| D952CM0025 | LayZir Disc AD98-22-LZ-BL1 |
| D952CM0024 | LayZir Disc AD98-20-LZ B1 |
| D952CM0023 | LayZir Disc AD98-20-LZ A3 |
| D952CM0022 | LayZir Disc AD98-20-LZ A2 |
| D952CM0021 | LayZir Disc AD98-20-LZ A1 |
| D952CM0020 | LayZir Disc AD98-20-LZ BL2 |
| D952CM0019 | LayZir Disc AD98-20-LZ BL1 |
| D952CM0018 | LayZir Disc AD98-18-LZ B1 |
| D952CM0017 | LayZir Disc AD98-18-LZ A3 |
| D952CM0016 | LayZir Disc AD98-18-LZ A2 |
| D952CM0015 | LayZir Disc AD98-18-LZ A1 |
| D952CM0014 | LayZir Disc AD98-18-LZ BL2 |
| D952CM0013 | LayZir Disc AD98-18-LZ BL1 |
| D952CM0012 | LayZir Disc AD98-16-LZ B1 |
| D952CM0011 | LayZir Disc AD98-16-LZ A3 |
| D952CM0010 | LayZir Disc AD98-16-LZ A2 |
| D952CM0009 | LayZir Disc AD98-16-LZ A1 |
| D952CM0008 | LayZir Disc AD98-16-LZ BL2 |
| D952CM0007 | LayZir Disc AD98-16-LZ BL1 |
| D952CM0006 | LayZir Disc AD98-14-LZ B1 |
| D952CM0005 | LayZir Disc AD98-14-LZ A3 |
| D952CM0004 | LayZir Disc AD98-14-LZ A2 |
| D952CM0003 | LayZir Disc AD98-14-LZ A1 |
| D952CM0002 | LayZir Disc AD98-14-LZ BL2 |
| D952CM0001 | LayZir Disc AD98-14-LZ BL1 |