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FDA 510(k)

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment

K-Number: K162890 · 2017-03-08

ApplicantStraumann USA, LLC
Decision Date2017-03-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment is a medical device manufactured by Straumann USA, LLC. It received FDA 510(k) clearance on 2017-03-08 under approval number K162890. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment?

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment is a medical device that received FDA 510(k) clearance on 2017-03-08. It is manufactured by Straumann USA, LLC. The 510(k) number is K162890.

When was BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment approved by the FDA?

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment received FDA 510(k) clearance on 2017-03-08, under approval number K162890.

What company makes BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment?

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment is manufactured by Straumann USA, LLC.

What is the FDA product code for BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment?

The FDA product code for BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment is DZE.

Related Clinical Trials

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 NCT07571408 Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease NOT_YET_RECRUITING NCT05615844 Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy RECRUITING NCT07251881 SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy NOT_YET_RECRUITING NCT07553689 Plasma Therapy for Diverse Wounds NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40947825 Definition of critical skin defect and concepts of structural and functional repairs: Proposal and verification in a rat model. Animal models and experimental medicine (2026)

Other Devices by Straumann USA, LLC

K151590Straumann RN Gold Abutment for Bridge K171784Straumann Dental Implant System K190662MRI Compatibility for Existing Straumann Dental Implant Systems K192401Straumann Screw-Retained Abutments K203753Straumann Surgical Cassettes K202942Straumann 4 mm Short Implants

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Related Devices (Code: DZE)

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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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