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FDA 510(k)

RESTORATIVE SYSTEM PROFILE

K-Number: K781293 · 1978-08-18

ApplicantThe S. S. White Co.
Decision Date1978-08-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESTORATIVE SYSTEM PROFILE is the device name listed in this FDA 510(k) record. The listed applicant is The S. S. White Co.. It received FDA 510(k) clearance on 1978-08-18 under 510(k) number K781293. 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 RESTORATIVE SYSTEM PROFILE?

RESTORATIVE SYSTEM PROFILE is a medical device that received FDA 510(k) clearance on 1978-08-18. The listed applicant is The S. S. White Co.. The 510(k) number is K781293.

When did RESTORATIVE SYSTEM PROFILE receive FDA 510(k) clearance?

RESTORATIVE SYSTEM PROFILE received FDA 510(k) clearance on 1978-08-18, under 510(k) number K781293.

Who is the listed applicant for RESTORATIVE SYSTEM PROFILE?

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

What is the FDA product code for RESTORATIVE SYSTEM PROFILE?

The FDA product code for RESTORATIVE SYSTEM PROFILE is EBF.

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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 The S. S. White 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.

K852744CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLORK852745PORCELAIN VENEER SYSTEM BONDING KITK853005S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARMK852743PORCELAIN VENEER SYSTEM LABORATORY KITK852182EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATERK837440UNKNOWN

View all 14 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.

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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