| Primary Device ID | 00810126041982 |
| NIH Device Record Key | 2bb1aa06-db9d-4836-8a0f-f083a7d592a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTFIT FINAL HYBRID DENTURE - 2 |
| Version Model Number | FNLHYD02 |
| Company DUNS | 796083090 |
| Company Name | HIOSSEN, 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810126041982 [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 | 2025-04-09 |
| Device Publish Date | 2025-04-01 |
| 00810125998652 - EK MULTI ANGLED ABUTMENT | 2026-02-12 |
| 00810125998669 - EK 30° Multi Angled abutment | 2026-02-12 |
| 00810125998676 - EK 30° Multi Angled abutment | 2026-02-12 |
| 00810125998683 - EK 30° Multi Angled abutment | 2026-02-12 |
| 00810126043153 - SM7 US ( Complete Set ) | 2026-01-19 SM7 complete set - The SM7 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used w |
| 00810126043160 - S200EML (Contra) Dental Surgery Hand Piece | 2026-01-19 S200EML (Contra) is intended for use in dental oral surgery and dental implant. The dental handpieces fitted with appropriate to |
| 00810126043245 - ETIII SA (Ø3.2mm) Pre-mounted | 2025-10-07 |
| 00810126043481 - ET III Fixture NH Regular Pre-Mounted | 2025-10-07 |