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FDA 510(k)

DENTAL MIRROR RETRACTOR

K-Number: K885040 · 1989-01-10

ApplicantNu-Lite Retractor, Inc.
Decision Date1989-01-10
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL MIRROR RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Nu-Lite Retractor, Inc.. It received FDA 510(k) clearance on 1989-01-10 under 510(k) number K885040. 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 DENTAL MIRROR RETRACTOR?

DENTAL MIRROR RETRACTOR is a medical device that received FDA 510(k) clearance on 1989-01-10. The listed applicant is Nu-Lite Retractor, Inc.. The 510(k) number is K885040.

When did DENTAL MIRROR RETRACTOR receive FDA 510(k) clearance?

DENTAL MIRROR RETRACTOR received FDA 510(k) clearance on 1989-01-10, under 510(k) number K885040.

Who is the listed applicant for DENTAL MIRROR RETRACTOR?

The FDA 510(k) record lists Nu-Lite Retractor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL MIRROR RETRACTOR?

The FDA product code for DENTAL MIRROR RETRACTOR is EKJ.

Related Clinical Trials

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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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

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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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