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FDA 510(k)

AMD DENTIST AND HYGIENIST KITS

K-Number: K925115 · 1994-07-05

ApplicantAdvance Medical Designs, Inc.
Decision Date1994-07-05
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMD DENTIST AND HYGIENIST KITS is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 1994-07-05 under 510(k) number K925115. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMD DENTIST AND HYGIENIST KITS?

AMD DENTIST AND HYGIENIST KITS is a medical device that received FDA 510(k) clearance on 1994-07-05. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K925115.

When did AMD DENTIST AND HYGIENIST KITS receive FDA 510(k) clearance?

AMD DENTIST AND HYGIENIST KITS received FDA 510(k) clearance on 1994-07-05, under 510(k) number K925115.

Who is the listed applicant for AMD DENTIST AND HYGIENIST KITS?

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

What is the FDA product code for AMD DENTIST AND HYGIENIST KITS?

The FDA product code for AMD DENTIST AND HYGIENIST KITS is EKJ.

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Other records listing Advance Medical Designs, Inc. as applicant

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Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, Inc.

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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