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FDA 510(k)

EMBRACE WET-BOND RESTORATIVE MATERIAL

K-Number: K031877 · 2003-08-01

ApplicantPulpdent Corporation
Decision Date2003-08-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMBRACE WET-BOND RESTORATIVE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K031877. 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 EMBRACE WET-BOND RESTORATIVE MATERIAL?

EMBRACE WET-BOND RESTORATIVE MATERIAL is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Pulpdent Corporation. The 510(k) number is K031877.

When did EMBRACE WET-BOND RESTORATIVE MATERIAL receive FDA 510(k) clearance?

EMBRACE WET-BOND RESTORATIVE MATERIAL received FDA 510(k) clearance on 2003-08-01, under 510(k) number K031877.

Who is the listed applicant for EMBRACE WET-BOND RESTORATIVE MATERIAL?

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

What is the FDA product code for EMBRACE WET-BOND RESTORATIVE MATERIAL?

The FDA product code for EMBRACE WET-BOND RESTORATIVE MATERIAL is EBF.

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Other records listing Pulpdent Corporation 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.

K210045ACTIVA PRESTO PACKK173020OBA-MCP, Orthodontic Bracket Adhesive with MCPK172169Pulpdent (Activa) Pit and Fissure Sealant with MCPK153249Pulpdent Solo Flowable Composite with MCPK130223RMGI FILLK123265RMGI LOW VISCOSITY

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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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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