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FDA 510(k)

THERMA-CURE

K-Number: K071590 · 2007-07-31

ApplicantReliance Orthodontic Products, Inc.
Decision Date2007-07-31
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THERMA-CURE is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2007-07-31 under 510(k) number K071590. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMA-CURE?

THERMA-CURE is a medical device that received FDA 510(k) clearance on 2007-07-31. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K071590.

When did THERMA-CURE receive FDA 510(k) clearance?

THERMA-CURE received FDA 510(k) clearance on 2007-07-31, under 510(k) number K071590.

Who is the listed applicant for THERMA-CURE?

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

What is the FDA product code for THERMA-CURE?

The FDA product code for THERMA-CURE is DYH.

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Related Devices (Code: DYH)

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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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