NobelReplace® S TiUnite® 302408
GUDID 07332747223293
NobelReplace® S TiUnite® NP 5.0x11.5mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747223293 |
| NIH Device Record Key | af65fdb3-deb5-4ad7-9065-ca7b2de9f479 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelReplace® S TiUnite® |
| Version Model Number | 302408 |
| Catalog Number | 302408 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com | |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com |
Device Dimensions
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 11.5 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 |
| 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 | 07332747223293 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K252197
FDA Product Code
| DZE | Implant, endosseous, root-form |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-06 |
| Device Publish Date | 2026-02-26 |
On-Brand Devices [NobelReplace® S TiUnite®]
| 07332747223316 | NobelReplace® S TiUnite® NP 5.0x16mm |
| 07332747223309 | NobelReplace® S TiUnite® NP 5.0x13mm |
| 07332747223293 | NobelReplace® S TiUnite® NP 5.0x11.5mm |
| 07332747223286 | NobelReplace® S TiUnite® NP 5.0x10mm |
| 07332747223279 | NobelReplace® S TiUnite® NP 5.0x8mm |
| 07332747223262 | NobelReplace® S TiUnite® NP 4.3x16mm |
| 07332747223255 | NobelReplace® S TiUnite® NP 4.3x13mm |
| 07332747223248 | NobelReplace® S TiUnite® NP 4.3x11.5mm |
| 07332747223231 | NobelReplace® S TiUnite® NP 4.3x10mm |
| 07332747223224 | NobelReplace® S TiUnite® NP 4.3x8mm |
| 07332747223217 | NobelReplace® S TiUnite® NP 3.5x16mm |
| 07332747223200 | NobelReplace® S TiUnite® NP 3.5x13mm |
| 07332747223194 | NobelReplace® S TiUnite® NP 3.5x11.5mm |
| 07332747223187 | NobelReplace® S TiUnite® NP 3.5x10mm |
| 07332747223170 | NobelReplace® S TiUnite® NP 3.5x8mm |
Trademark Results [NobelReplace]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELREPLACE 79028282 not registered Dead/Abandoned |
Nobel Biocare AB 2006-02-14 |
NOBELREPLACE 79028282 not registered Dead/Abandoned |
Nobel Biocure Services AG 2006-02-14 |
 NOBELREPLACE 79018918 3211602 Live/Registered |
Nobel Biocure Services AG 2005-07-13 |
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