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FDA 510(k)

MIRROR SHIELD

K-Number: K901053 · 1990-05-07

ApplicantPulpdent Corp.
Decision Date1990-05-07
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIRROR SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K901053. 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 MIRROR SHIELD?

MIRROR SHIELD is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is Pulpdent Corp.. The 510(k) number is K901053.

When did MIRROR SHIELD receive FDA 510(k) clearance?

MIRROR SHIELD received FDA 510(k) clearance on 1990-05-07, under 510(k) number K901053.

Who is the listed applicant for MIRROR SHIELD?

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

What is the FDA product code for MIRROR SHIELD?

The FDA product code for MIRROR SHIELD is EKJ.

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Other records listing Pulpdent Corp. 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.

K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION III

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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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