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FDA 510(k)

SUMMA DISK

K-Number: K833038 · 1983-10-04

ApplicantShofu Dental Corp.
Decision Date1983-10-04
Product CodeDZP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUMMA DISK is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K833038. The device is classified under product code DZP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUMMA DISK?

SUMMA DISK is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Shofu Dental Corp.. The 510(k) number is K833038.

When did SUMMA DISK receive FDA 510(k) clearance?

SUMMA DISK received FDA 510(k) clearance on 1983-10-04, under 510(k) number K833038.

Who is the listed applicant for SUMMA DISK?

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

What is the FDA product code for SUMMA DISK?

The FDA product code for SUMMA DISK is DZP.

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Other records listing Shofu Dental Corp. 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.

K111855HY-BOND RESIGLASSK110235BEAUTIBOND MULTIK110252BEAUTIBOND MULTI PR PLUSK101621LITE ARTK101603BEAUTIFIL FLOW PLUSK093559VINTAGE MP

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Related Devices (Code: DZP)

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.

K120037BLUWHITE DIAMOND DENTAL BURS MODIFIEDBeavers Dental, Div. Sybron Canada, Ltd.K943841SOPHOS DENTAL DIAMONDSophos TechnologicK940908DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURSDunhall Pharmaceuticals, Inc.K934981DENTAL DRILLEare Consulting ServiceK923757DENTAL DIAMOND DRILLSAlpha Industrializacao DE Metais Ltda.K913651MANI DIA-BURSThe Lahr Consulting Group, 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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