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FDA 510(k)

NUVA-FIL COMPOSITE RESTORATIVE (MODI.)

K-Number: K771404 · 1977-08-03

ApplicantL.D. Caulk Co.
Decision Date1977-08-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUVA-FIL COMPOSITE RESTORATIVE (MODI.) is the device name listed in this FDA 510(k) record. The listed applicant is L.D. Caulk Co.. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771404. 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 NUVA-FIL COMPOSITE RESTORATIVE (MODI.)?

NUVA-FIL COMPOSITE RESTORATIVE (MODI.) is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is L.D. Caulk Co.. The 510(k) number is K771404.

When did NUVA-FIL COMPOSITE RESTORATIVE (MODI.) receive FDA 510(k) clearance?

NUVA-FIL COMPOSITE RESTORATIVE (MODI.) received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771404.

Who is the listed applicant for NUVA-FIL COMPOSITE RESTORATIVE (MODI.)?

The FDA 510(k) record lists L.D. Caulk Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUVA-FIL COMPOSITE RESTORATIVE (MODI.)?

The FDA product code for NUVA-FIL COMPOSITE RESTORATIVE (MODI.) 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.

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Other records listing L.D. Caulk Co. 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.

K802262COMPOSITE RESTORATIVEK801690VALIANTK790586CHEMBONDK790585FINESSEK780560DENTAL AMALGAMATORK780384IMPROVED DYCAL

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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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