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)

TPH Spectra+ Universal Composite Restorative

K-Number: K162107 · 2016-09-27

ApplicantDentsply Sirona
Decision Date2016-09-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TPH Spectra+ Universal Composite Restorative is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K162107. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TPH Spectra+ Universal Composite Restorative?

TPH Spectra+ Universal Composite Restorative is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Dentsply Sirona. The 510(k) number is K162107.

When did TPH Spectra+ Universal Composite Restorative receive FDA 510(k) clearance?

TPH Spectra+ Universal Composite Restorative received FDA 510(k) clearance on 2016-09-27, under 510(k) number K162107.

Who is the listed applicant for TPH Spectra+ Universal Composite Restorative?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TPH Spectra+ Universal Composite Restorative?

The FDA product code for TPH Spectra+ Universal Composite Restorative is EBF.

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.

NCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITING

Other records listing Dentsply Sirona 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.

K260785DS Core CBCT AnatomyK260722SureSmile Aligner (ASSY500020)K253565SureSmile SoftwareK251614Stainless Steel Surgical KitsK253959Primevision 3DK253009DS Core Detect

View all 86 devices →

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., 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.

↑