Primary Device ID | 00810063330774 |
NIH Device Record Key | 0ec2023b-fc23-47ef-82e1-8d20d36054c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aeton Medical |
Version Model Number | AMSTAS655 |
Company DUNS | 043000598 |
Company Name | Aetonmedical LLC |
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 | false |
Manufacturing Date | false |
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 | 00810063330774 [Primary] |
DZE | Implant, Endosseous, Root-Form |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
[00810063330774]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-07-02 |
Device Publish Date | 2020-11-11 |
00810063330583 | Healing Cap 4.8mm X 3.5mm, Nar Conical |
00810063330705 | Healing Cap 6.0mm X 3.5mm, Reg Conical |
00810063330774 | ST Abutment Set - 6.5mm X 5.5mm |
00810063330767 | ST Abutment Set - 6.5mm X 4.0mm |
00810063330750 | ST Abutment Set - 4.8mm X 7.0mm |
00810063330743 | ST Abutment Set - 4.8mm X 5.5mm |
00810063330736 | ST Abutment Set - 4.8mm X 4.0mm |