- FDA cleared the N1 TiUltra TCC implant system in December 2021 (K211109).1
- The implant–abutment connection is tri-oval, not the round conical connection used by NobelActive®, NobelParallel™ and NobelReplace® implants. Parts are not interchangeable.1
- Abutments include the N1 Base Xeal™ and a Multi-unit Abutment Xeal™ for N1.1
- Most published data so far come from the manufacturer; long-term independent studies are still limited.2
What makes N1 different
Most implant systems prepare the bone with a series of drills of increasing size. With N1, the surgeon uses a small number of drills and then the OsseoShaper™, a shaping instrument. According to a study written by Nobel Biocare employees, the torque the surgeon feels while using it correlates with bone density and predicts how firmly the implant will seat.2
A study by Nobel Biocare employees reported that the torque measured with the OsseoShaper™ instrument correlated strongly with bone density and predicted implant insertion torque. 2
Manufacturer-authored laboratory and early clinical data. Independent long-term clinical studies of the N1™ system are still limited.
The implant sits on a tri-oval conical connection: three rounded lobes that lock the abutment in position.1 This is a different connection from Nobel Biocare's established round conical connection, so N1 parts cannot be mixed with NobelActive® or S Series parts.
Surface and abutments
N1 implants have the TiUltra™ surface, an anodised surface whose properties change gradually from collar to tip.3 Abutments for N1 include the N1 Base Xeal™ and a Multi-unit Abutment Xeal™.1
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Request an assessmentRecall records you should know about
FDA's recall database lists two open recall records involving N1 products. Both concern items co-packed with the implant, not the implant body itself:4
- Z-1565-2022 (July 2022): a possible burr on the co-packed OsseoShaper™ instrument for N1 TiUltra TCC NP 3.5 × 13 mm, with a risk of the patient swallowing or inhaling it during surgery.4
- Z-1101-2025 (January 2025): a sharp pin from the plastic packaging insert could puncture the blister and breach the sterile barrier for N1 TiUltra TCC RP 4.0 mm implants (9, 11, 13 mm).4
"Open" means FDA has not yet marked the recall as completed. It does not mean implants already placed in patients are faulty. If you have an N1 implant, your implant passport shows the reference and lot number your clinic can check.
What the evidence does and does not show
N1 is recent. Published work to date is mainly laboratory and early clinical data, much of it from the manufacturer.2 That does not mean it performs worse. It means long-term independent results (10 years and more) are not yet available the way they are for older lines such as TiUnite® implants.5
Frequently asked questions
Is N1 the same as NobelActive?
Does N1 hurt less because there is less drilling?
Can any clinic restore an N1 implant later?
Last updated 28 Sep 2026 · How we review
Sources
- Regulatory recordFDA 510(k) K211109 — N1 TiUltra TCC Implant System (Nobel Biocare) — U.S. Food and Drug Administration, 2021-12-21. Accessed 28 Sep 2026.
- Manufacturer-sponsored researchVelikov S et al. A new site preparation protocol that supports bone quality evaluation and predictable insertion torque (OsseoShaper). J Clin Med 2020 — J Clin Med, 2020. Accessed 28 Sep 2026.
- Regulatory recordFDA 510(k) K202344 — TiUltra Implants and Xeal Abutments (Nobel Biocare) — U.S. Food and Drug Administration, 2020-11-16. Accessed 28 Sep 2026.
- Regulatory recordopenFDA device recall database — records with recalling firm "Nobel Biocare" (76 records) — U.S. Food and Drug Administration (openFDA), 2026-09-28. Accessed 28 Sep 2026.
- Systematic reviewKarl M, Albrektsson T. Clinical performance of implants with a moderately rough (TiUnite) surface: meta-analysis of prospective studies. Int J Oral Maxillofac Implants 2017 — Int J Oral Maxillofac Implants, 2017. Accessed 28 Sep 2026.
- Manufacturer documentationNobel Biocare — CC implants and prosthetics product overview 25.1 (95092) — Nobel Biocare Services AG, 2025. Accessed 28 Sep 2026.
Educational information only. The choice of implant system depends on your anatomy, restorative plan, bone quality and the clinician's assessment. This website does not recommend a specific implant for you.
