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FDA 510(k)

BRACKET BONDING SYSTEM METAL & PLASTIC

K-Number: K800392 · 1980-04-10

ApplicantAmerican Dental Research
Decision Date1980-04-10
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRACKET BONDING SYSTEM METAL & PLASTIC is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Research. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800392. 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 BRACKET BONDING SYSTEM METAL & PLASTIC?

BRACKET BONDING SYSTEM METAL & PLASTIC is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is American Dental Research. The 510(k) number is K800392.

When did BRACKET BONDING SYSTEM METAL & PLASTIC receive FDA 510(k) clearance?

BRACKET BONDING SYSTEM METAL & PLASTIC received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800392.

Who is the listed applicant for BRACKET BONDING SYSTEM METAL & PLASTIC?

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

What is the FDA product code for BRACKET BONDING SYSTEM METAL & PLASTIC?

The FDA product code for BRACKET BONDING SYSTEM METAL & PLASTIC is DYH.

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Other records listing American Dental Research 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.

K800389ANTERIOR & POST. RESTORATIVE PASTE SYS.K800391PAINT-ON-RESTORATIVE W/FISSURE SEALERK800390ANT. & POST. RESTORATIVE POWDER LIQ.K800393POLY SULFIDE IMPRESSION PASTE W/CATALYST

Related Devices (Code: DYH)

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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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