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FDA 510(k)

TROPHY COMPACT - DENTAL UNIT

K-Number: K851136 · 1985-07-31

Decision Date1985-07-31
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TROPHY COMPACT - DENTAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Trophy Radiologie. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K851136. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROPHY COMPACT - DENTAL UNIT?

TROPHY COMPACT - DENTAL UNIT is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is Trophy Radiologie. The 510(k) number is K851136.

When did TROPHY COMPACT - DENTAL UNIT receive FDA 510(k) clearance?

TROPHY COMPACT - DENTAL UNIT received FDA 510(k) clearance on 1985-07-31, under 510(k) number K851136.

Who is the listed applicant for TROPHY COMPACT - DENTAL UNIT?

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

What is the FDA product code for TROPHY COMPACT - DENTAL UNIT?

The FDA product code for TROPHY COMPACT - DENTAL UNIT is EIA.

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.

Other records listing Trophy Radiologie 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.

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Related Devices (Code: EIA)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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