NobelParallel™ S TiUnite® 302376
GUDID 07332747222975
NobelParallel™ S TiUnite® NP 4.3x11.5mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747222975 |
| NIH Device Record Key | 6be8fb64-4b43-445b-bc1f-fb4612af574d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelParallel™ S TiUnite® |
| Version Model Number | 302376 |
| Catalog Number | 302376 |
| 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 | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 4.3 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 | 07332747222975 [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 [NobelParallel™ S TiUnite®]
| 07332747223163 | NobelParallel™ S TiUnite® NP 5.5x15mm |
| 07332747223156 | NobelParallel™ S TiUnite® NP 5.5x13mm |
| 07332747223149 | NobelParallel™ S TiUnite® NP 5.5x11.5mm |
| 07332747223132 | NobelParallel™ S TiUnite® NP 5.5x10mm |
| 07332747223125 | NobelParallel™ S TiUnite® NP 5.5x8.5mm |
| 07332747223118 | NobelParallel™ S TiUnite® NP 5.5x7mm |
| 07332747223101 | NobelParallel™ S TiUnite® NP 5.0x18mm |
| 07332747223095 | NobelParallel™ S TiUnite® NP 5.0x15mm |
| 07332747223088 | NobelParallel™ S TiUnite® NP 5.0x13mm |
| 07332747223071 | NobelParallel™ S TiUnite® NP 5.0x11.5mm |
| 07332747223064 | NobelParallel™ S TiUnite® NP 5.0x10mm |
| 07332747223057 | NobelParallel™ S TiUnite® NP 5.0x8.5mm |
| 07332747223040 | NobelParallel™ S TiUnite® NP 5.0x7mm |
| 07332747223002 | NobelParallel™ S TiUnite® NP 4.3x18mm |
| 07332747222999 | NobelParallel™ S TiUnite® NP 4.3x15mm |
| 07332747222982 | NobelParallel™ S TiUnite® NP 4.3x13mm |
| 07332747222975 | NobelParallel™ S TiUnite® NP 4.3x11.5mm |
| 07332747222968 | NobelParallel™ S TiUnite® NP 4.3x10mm |
| 07332747222951 | NobelParallel™ S TiUnite® NP 4.3x8.5mm |
| 07332747222944 | NobelParallel™ S TiUnite® NP 4.3x7mm |
| 07332747222937 | NobelParallel™ S TiUnite® NP 3.75x18mm |
| 07332747222920 | NobelParallel™ S TiUnite® NP 3.75x15mm |
| 07332747222913 | NobelParallel™ S TiUnite® NP 3.75x13mm |
| 07332747222906 | NobelParallel™ S TiUnite® NP 3.75x11.5mm |
| 07332747222890 | NobelParallel™ S TiUnite® NP 3.75x10mm |
| 07332747222883 | NobelParallel™ S TiUnite® NP 3.75x8.5mm |
| 07332747222876 | NobelParallel™ S TiUnite® NP 3.75x7mm |
Trademark Results [NobelParallel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELPARALLEL 79359418 not registered Live/Pending |
Nobel Biocare Services AG 2022-09-15 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.