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FDA 510(k)

F-11 REFLECTOR / F-II STANDARD REFLECTOR

K-Number: K863019 · 1986-09-29

ApplicantSds Dental, Inc.
Decision Date1986-09-29
Product CodeEAZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

F-11 REFLECTOR / F-II STANDARD REFLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Sds Dental, Inc.. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863019. The device is classified under product code EAZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F-11 REFLECTOR / F-II STANDARD REFLECTOR?

F-11 REFLECTOR / F-II STANDARD REFLECTOR is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Sds Dental, Inc.. The 510(k) number is K863019.

When did F-11 REFLECTOR / F-II STANDARD REFLECTOR receive FDA 510(k) clearance?

F-11 REFLECTOR / F-II STANDARD REFLECTOR received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863019.

Who is the listed applicant for F-11 REFLECTOR / F-II STANDARD REFLECTOR?

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

What is the FDA product code for F-11 REFLECTOR / F-II STANDARD REFLECTOR?

The FDA product code for F-11 REFLECTOR / F-II STANDARD REFLECTOR is EAZ.

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Other records listing Sds Dental, 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.

K990546DELSONIC 2000K990545JETSONIC 2000K964619DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)K902865BAUMER SURGICAL TABLEK902864SURGICAL LIGHTING-CENTRA 450K863011DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II

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Related Devices (Code: EAZ)

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.

K072309MICROLUX/BLUAddent, Inc.K041614MICROLUX DLAddent, Inc.K033033VIZILITE-BLUE ORAL EXAM KITTrylon Corp.K003995SPECULITE/ORALLITETrylon Corp.K926081DENTAL LIGHTMdt Corp., Inc.K935390SIROLUX FANTASTICPelton & Crane Co.

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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