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 |