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FDA 510(k)

DENTACOLOR LIGHT CURING CROWN & BRIDGE

K-Number: K831215 · 1983-09-12

ApplicantKulzer, Inc.
Decision Date1983-09-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTACOLOR LIGHT CURING CROWN & BRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831215. 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 DENTACOLOR LIGHT CURING CROWN & BRIDGE?

DENTACOLOR LIGHT CURING CROWN & BRIDGE is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Kulzer, Inc.. The 510(k) number is K831215.

When did DENTACOLOR LIGHT CURING CROWN & BRIDGE receive FDA 510(k) clearance?

DENTACOLOR LIGHT CURING CROWN & BRIDGE received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831215.

Who is the listed applicant for DENTACOLOR LIGHT CURING CROWN & BRIDGE?

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

What is the FDA product code for DENTACOLOR LIGHT CURING CROWN & BRIDGE?

The FDA product code for DENTACOLOR LIGHT CURING CROWN & BRIDGE is EBF.

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Other records listing Kulzer, Inc. as applicant

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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.

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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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