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FDA 510(k)

CALC-I-OSS

K-Number: K042583 · 2005-07-19

ApplicantUltradent Products, Inc.
Decision Date2005-07-19
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALC-I-OSS is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2005-07-19 under 510(k) number K042583. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALC-I-OSS?

CALC-I-OSS is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K042583.

When did CALC-I-OSS receive FDA 510(k) clearance?

CALC-I-OSS received FDA 510(k) clearance on 2005-07-19, under 510(k) number K042583.

Who is the listed applicant for CALC-I-OSS?

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

What is the FDA product code for CALC-I-OSS?

The FDA product code for CALC-I-OSS is LYC.

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Related Devices (Code: LYC)

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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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