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FDA 510(k)

DENTAL MATRIX BAND

K-Number: K822094 · 1982-08-16

ApplicantDentsply Intl.
Decision Date1982-08-16
Product CodeDZN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL MATRIX BAND is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822094. The device is classified under product code DZN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL MATRIX BAND?

DENTAL MATRIX BAND is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Dentsply Intl.. The 510(k) number is K822094.

When did DENTAL MATRIX BAND receive FDA 510(k) clearance?

DENTAL MATRIX BAND received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822094.

Who is the listed applicant for DENTAL MATRIX BAND?

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

What is the FDA product code for DENTAL MATRIX BAND?

The FDA product code for DENTAL MATRIX BAND is DZN.

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Other records listing Dentsply Intl. as applicant

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Related Devices (Code: DZN)

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.

K111465COMPOTHIXOKerrhawe SAK071858DENTAL MATRIX BANDFly Cast Technologies, Inc.K901919CONTACT MOLAR BANDS AND CONTOUR STRIPSIvoclar North America, Inc.K861581CENTRIX PCR MOLAR MATRIX FORMS (BANDS)Centrix, Inc.K844324TIGER BANDWorld Wide Outdoor MarketingK840984INTERDENTAL WEDGESHealthco, 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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