| Primary Device ID | H668166210 |
| NIH Device Record Key | 8effa076-711a-4f40-a5e8-d8987f994602 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cora-Caine |
| Version Model Number | 16621 |
| Catalog Number | 16621 |
| Company DUNS | 073503117 |
| Company Name | Keystone Industries |
| Device Count | 36 |
| 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 | true |
| Single Use | true |
| 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 | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H668166210 [Unit of Use] |
| HIBCC | H668166211 [Primary] |
| KOP | ADHESIVE, DENTURE, KARAYA |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| H66842204401 - Carbon | 2025-09-05 FP3D Original Pink |
| H66842204411 - Carbon | 2025-09-05 FP3D Light Reddish Pink |
| H66842204421 - Carbon | 2025-09-05 FP3D Dark Veined |
| H66842004331 - KeyPrint | 2025-01-15 KeyDenture Base Light Pink 0.5kg |
| H66842004341 - KeyPrint | 2025-01-15 KeyDenture Base Light Reddish Pink 0.5kg |
| H66842204301 - KeyPrint | 2025-01-15 KeyDenture Base Original 1kg |
| H66842204311 - KeyPrint | 2025-01-15 KeyDenture Base Dark Veined 1kg |
| H66842204321 - KeyPrint | 2025-01-15 KeyDenture Base Chroma Essence 1kg |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CORA-CAINE 72024125 0663034 Live/Registered |
CORALITE DENTAL PRODUCTS 1957-02-11 |