Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2017-03-08 under 510(k) 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. The listed applicant is Straumann USA, LLC. The 510(k) number is K162890.

When did BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment receive FDA 510(k) clearance?

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 510(k) number K162890.

Who is the listed applicant 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 510(k) record lists Straumann USA, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05122897Investigation of Biofilm Formation on Temporary push-on Rings of Implant CrownsRECRUITINGNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07624331Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant RestorationsRECRUITINGNCT07744776Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ)RECRUITINGNCT07782125Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue DefectsRECRUITING

Other records listing Straumann USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241575Straumann® Anatomic Healing Abutments XC (AHA)K203753Straumann Surgical CassettesK202942Straumann 4 mm Short ImplantsK192401Straumann Screw-Retained AbutmentsK190662MRI Compatibility for Existing Straumann Dental Implant SystemsK171784Straumann Dental Implant System

View all 9 devices →

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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.

↑