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FDA 510(k)

#23 EXPLORER

K-Number: K901176 · 1990-04-16

ApplicantAmerican Medical Ceramics, Inc.
Decision Date1990-04-16
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

#23 EXPLORER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Ceramics, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K901176. 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 #23 EXPLORER?

#23 EXPLORER is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is American Medical Ceramics, Inc.. The 510(k) number is K901176.

When did #23 EXPLORER receive FDA 510(k) clearance?

#23 EXPLORER received FDA 510(k) clearance on 1990-04-16, under 510(k) number K901176.

Who is the listed applicant for #23 EXPLORER?

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

What is the FDA product code for #23 EXPLORER?

The FDA product code for #23 EXPLORER is EKJ.

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Other records listing American Medical Ceramics, Inc. 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.

K901178AMALGAM CONDENSERK901175HAND MIRRORK901173DISCOID SPOON EXCAVATORK901174ELEVATOR #11K901170PERIODONTAL KNIFEK901172GRACEY CURETTE #13-14

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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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