| Primary Device ID | 06977274260253 |
| NIH Device Record Key | 885938ed-a194-49de-bcc7-47b4a3cbf2ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intraoral Scanner |
| Version Model Number | HCE-IS-130 |
| Company DUNS | 550050296 |
| Company Name | Changsha Honchon Technology Co., LTD |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06977274260253 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
[06977274260253]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-08 |
| Device Publish Date | 2025-08-31 |
| 06977274260284 | HCE-IS-800 |
| 06977274260277 | HCE-IS-500 |
| 06977274260260 | HCE-IS-300 |
| 06977274260253 | HCE-IS-130 |