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FDA 510(k)

COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM

K-Number: K022224 · 2002-09-18

ApplicantColtene AG
Decision Date2002-09-18
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coltene AG. It received FDA 510(k) clearance on 2002-09-18 under 510(k) number K022224. 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 COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM?

COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-09-18. The listed applicant is Coltene AG. The 510(k) number is K022224.

When did COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM receive FDA 510(k) clearance?

COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM received FDA 510(k) clearance on 2002-09-18, under 510(k) number K022224.

Who is the listed applicant for COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM?

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

What is the FDA product code for COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM?

The FDA product code for COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM is DYH.

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Other records listing Coltene AG 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.

K041098COOL TEMP NATURAL

Related Devices (Code: DYH)

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

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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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