NobelActive 35215
GUDID 07332747017922
NobelActive® Internal NP 3.5x18mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece| Primary Device ID | 07332747017922 |
| NIH Device Record Key | f4ef9d3b-3b2a-4da9-b697-0cf95e5f43e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelActive |
| Version Model Number | 35215 |
| Catalog Number | 35215 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747017922 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083205
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2015-09-17 |
On-Brand Devices [NobelActive]
| 07332747017977 | NobelActive® Internal RP 5.0x8.5mm |
| 07332747017960 | NobelActive® Internal RP 5.0x18mm |
| 07332747017953 | NobelActive® Internal RP 4.3x8.5mm |
| 07332747017946 | NobelActive® Internal RP 4.3x18mm |
| 07332747017939 | NobelActive® Internal NP 3.5x8.5mm |
| 07332747017922 | NobelActive® Internal NP 3.5x18mm |
| 07332747010695 | NobelActive® Internal RP 5.0x15mm |
| 07332747010688 | NobelActive® Internal RP 5.0x13mm |
| 07332747010671 | NobelActive® Internal RP 5.0x11.5mm |
| 07332747010664 | NobelActive® Internal RP 5.0x10mm |
| 07332747010657 | NobelActive® Internal RP 4.3x15mm |
| 07332747010640 | NobelActive® Internal RP 4.3x13mm |
| 07332747010633 | NobelActive® Internal RP 4.3x11.5mm |
| 07332747010626 | NobelActive® Internal RP 4.3x10mm |
| 07332747010619 | NobelActive® Internal NP 3.5x15mm |
| 07332747010602 | NobelActive® Internal NP 3.5x13mm |
| 07332747010596 | NobelActive® Internal NP 3.5x11.5mm |
| 07332747010589 | NobelActive® Internal NP 3.5x10mm |
Trademark Results [NobelActive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELACTIVE 79060037 3635600 Live/Registered |
Nobel Biocare Services AG 2008-07-15 |
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