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FDA 510(k)

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants

K-Number: K251205 · 2025-11-21

ApplicantDentsply Sirona
Decision Date2025-11-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2025-11-21 under approval number K251205. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants?

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Dentsply Sirona. The 510(k) number is K251205.

When was Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants approved by the FDA?

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants received FDA 510(k) clearance on 2025-11-21, under approval number K251205.

What company makes Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants?

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is manufactured by Dentsply Sirona.

What is the FDA product code for Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants?

The FDA product code for Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is NHA.

Related Clinical Trials

NCT06430268 Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants ENROLLING_BY_INVITATION NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT06086873 Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA RECRUITING

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K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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