| Primary Device ID | 07332747176193 |
| NIH Device Record Key | 860c8b17-8c6b-4d14-9829-4761b89f308e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | On1™ |
| Version Model Number | 38728 |
| Catalog Number | 38728 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| 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 |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747176193 [Primary] |
| NDP | Accessories, implant, dental, endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
[07332747176193]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-31 |
| Device Publish Date | 2023-08-23 |
| 07332747194142 | On1 Esthetic Abutment Titanium 0.3 mm NP |
| 07332747176421 | Pos Loc Single Abut Nobel Biocare On1 |
| 07332747128741 | On1 Impression Coping Open Tray N-Eng WP |
| 07332747128734 | On1 Impression Coping Open Tray N-Eng RP |
| 07332747128727 | On1 Impression Coping Open Tray N-Eng NP |
| 07332747176285 | On1 Prosthetic Lab Screw NP/RP/WP |
| 07332747176278 | On1 IOS Replica WP |
| 07332747176261 | On1 IOS Replica RP |
| 07332747176254 | On1 IOS Replica NP |
| 07332747176247 | On1 Base Replica WP |
| 07332747176230 | On1 Base Replica RP |
| 07332747176223 | On1 Base Replica NP |
| 07332747113686 | On1 Base Replica WP |
| 07332747113679 | On1 Base Replica RP |
| 07332747113662 | On1 Base Replica NP |
| 07332747176209 | On1 Impression Coping Open Tray RP |
| 07332747176193 | On1 Impression Coping Open Tray NP |
| 07332747176162 | On1 Impression Coping Closed Tray NP |
| 07332747176216 | On1 Impression Coping Open Tray WP |
| 07332747176186 | On1 Impression Coping Closed Tray WP |
| 07332747176179 | On1 Impression Coping Closed Tray RP |
| 07332747191943 | On1 Prosthetic Screw NP/RP/WP |
| 07332747191936 | On1 Clinical Screw 2.5 mm WP |
| 07332747191929 | On1 Clinical Screw 1.75 mm WP |
| 07332747191912 | On1 Clinical Screw 2.5 mm RP |
| 07332747191905 | On1 Clinical Screw 1.75 mm RP |
| 07332747191899 | On1 Clinical Screw 2.5 mm NP |
| 07332747191882 | On1 Clinical Screw 1.75 mm NP |
| 07332747191875 | On1 IOS Healing Cap 4 mm WP |
| 07332747191868 | On1 IOS Healing Cap 5 mm WP |
| 07332747191851 | On1 IOS Healing Cap 4.5 mm RP |
| 07332747191844 | On1 IOS Healing Cap 6 mm RP |
| 07332747191837 | On1 IOS Healing Cap 4.5 mm NP |
| 07332747191820 | On1 IOS Healing Cap 6 mm NP |
| 07332747191806 | On1 Temporary Abutment Engaging WP |
| 07332747191783 | On1 Temporary Abutment Engaging RP |
| 07332747191769 | On1 Temporary Abutment Engaging NP |
| 07332747191752 | On1 Healing Cap WP 2.5 mm |
| 07332747191745 | On1 Healing Cap WP 1.5 mm |
| 07332747191738 | On1 Healing Cap RP 2.5 mm |
| 07332747191721 | On1 Healing Cap RP 1.5 mm |
| 07332747191714 | On1 Healing Cap NP 2.5 mm |
| 07332747191707 | On1 Healing Cap NP 1.5 mm |
| 07332747191691 | On1 Base CC WP 2.5 mm |
| 07332747191684 | On1 Base CC WP 1.75 mm |
| 07332747191677 | On1 Base CC RP 2.5 mm |
| 07332747191660 | On1 Base CC RP 1.75 mm |
| 07332747191653 | On1 Base CC NP 2.5 mm |
| 07332747191646 | On1 Base CC NP 1.75 mm |
| 07332747188394 | On1 Base Xeal™ Conical Connection WP 2.5mm |