NobelActive® TiUltra™ 300253
GUDID 07332747127447
NobelActive® TiUltra™ RP 4.3x13mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747127447 |
| NIH Device Record Key | 8270bd3e-5119-477e-b1a6-3d81aa66186d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelActive® TiUltra™ |
| Version Model Number | 300253 |
| Catalog Number | 300253 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| 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 | true |
| 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
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com |
Device Dimensions
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 13 Millimeter |
| Outer Diameter | 4.3 Millimeter |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747127447 [Primary] |
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 | 2 |
| Public Version Date | 2021-10-25 |
| Device Publish Date | 2020-11-18 |
On-Brand Devices [NobelActive® TiUltra™]
| 07332747127584 | NobelActive® TiUltra™ WP 5.5x15mm |
| 07332747127577 | NobelActive® TiUltra™ WP 5.5x13mm |
| 07332747127560 | NobelActive® TiUltra™ WP 5.5x11.5mm |
| 07332747127553 | NobelActive® TiUltra™ WP 5.5x7mm |
| 07332747127546 | NobelActive® TiUltra™ WP 5.5x10mm |
| 07332747127539 | NobelActive® TiUltra™ WP 5.5x8.5mm |
| 07332747127522 | NobelActive® TiUltra™ RP 5.0x18mm |
| 07332747127515 | NobelActive® TiUltra™ RP 5.0x15mm |
| 07332747127508 | NobelActive® TiUltra™ RP 5.0x13mm |
| 07332747127492 | NobelActive® TiUltra™ RP 5.0x11.5mm |
| 07332747127485 | NobelActive® TiUltra™ RP 5.0x10mm |
| 07332747127478 | NobelActive® TiUltra™ RP 5.0x8.5mm |
| 07332747127461 | NobelActive® TiUltra™ RP 4.3x18mm |
| 07332747127454 | NobelActive® TiUltra™ RP 4.3x15mm |
| 07332747127447 | NobelActive® TiUltra™ RP 4.3x13mm |
| 07332747127430 | NobelActive® TiUltra™ RP 4.3x11.5mm |
| 07332747127423 | NobelActive® TiUltra™ RP 4.3x10mm |
| 07332747127416 | NobelActive® TiUltra™ RP 4.3x8.5mm |
| 07332747127409 | NobelActive® TiUltra™ NP 3.5x18mm |
| 07332747127393 | NobelActive® TiUltra™ NP 3.5x15mm |
| 07332747127386 | NobelActive® TiUltra™ NP 3.5x13mm |
| 07332747127379 | NobelActive® TiUltra™ NP 3.5x11.5mm |
| 07332747127362 | NobelActive® TiUltra™ NP 3.5x10mm |
| 07332747127355 | NobelActive® TiUltra™ NP 3.5x8.5mm |
| 07332747127348 | NobelActive® TiUltra™ 3.0 3.0x15mm |
| 07332747127331 | NobelActive® TiUltra™ 3.0 3.0x13mm |
| 07332747127324 | NobelActive® TiUltra™ 3.0 3.0x11.5mm |
| 07332747127317 | NobelActive® TiUltra™ 3.0 3.0x10mm |
Trademark Results [NobelActive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELACTIVE 79060037 3635600 Live/Registered |
Nobel Biocare Services AG 2008-07-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.