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FDA 510(k)

SPECTRUM CURING LIGHT POLYMERIZATION UNIT

K-Number: K951425 · 1995-05-05

ApplicantDentsply Intl.
Decision Date1995-05-05
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPECTRUM CURING LIGHT POLYMERIZATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K951425. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM CURING LIGHT POLYMERIZATION UNIT?

SPECTRUM CURING LIGHT POLYMERIZATION UNIT is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Dentsply Intl.. The 510(k) number is K951425.

When did SPECTRUM CURING LIGHT POLYMERIZATION UNIT receive FDA 510(k) clearance?

SPECTRUM CURING LIGHT POLYMERIZATION UNIT received FDA 510(k) clearance on 1995-05-05, under 510(k) number K951425.

Who is the listed applicant for SPECTRUM CURING LIGHT POLYMERIZATION UNIT?

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 SPECTRUM CURING LIGHT POLYMERIZATION UNIT?

The FDA product code for SPECTRUM CURING LIGHT POLYMERIZATION UNIT is EBZ.

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Related Devices (Code: EBZ)

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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