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FDA 510(k)

DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II

K-Number: K863011 · 1986-10-10

ApplicantSds Dental, Inc.
Decision Date1986-10-10
Product Code
DecisionSubstantially Equivalent

Device Summary

DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II 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 1986-10-10 under 510(k) number K863011. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II?

DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II is a medical device that received FDA 510(k) clearance on 1986-10-10. The listed applicant is Sds Dental, Inc.. The 510(k) number is K863011.

When did DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II receive FDA 510(k) clearance?

DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II received FDA 510(k) clearance on 1986-10-10, under 510(k) number K863011.

Who is the listed applicant for DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II?

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

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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 450K863015ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT

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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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