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FDA 510(k)

B&L L-BETA, MODEL WL-B1

K-Number: K060347 · 2006-06-05

ApplicantB&L Biotech Co., Ltd.
Decision Date2006-06-05
Product CodeEKR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

B&L L-BETA, MODEL WL-B1 is the device name listed in this FDA 510(k) record. The listed applicant is B&L Biotech Co., Ltd.. It received FDA 510(k) clearance on 2006-06-05 under 510(k) number K060347. The device is classified under product code EKR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B&L L-BETA, MODEL WL-B1?

B&L L-BETA, MODEL WL-B1 is a medical device that received FDA 510(k) clearance on 2006-06-05. The listed applicant is B&L Biotech Co., Ltd.. The 510(k) number is K060347.

When did B&L L-BETA, MODEL WL-B1 receive FDA 510(k) clearance?

B&L L-BETA, MODEL WL-B1 received FDA 510(k) clearance on 2006-06-05, under 510(k) number K060347.

Who is the listed applicant for B&L L-BETA, MODEL WL-B1?

The FDA 510(k) record lists B&L Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B&L L-BETA, MODEL WL-B1?

The FDA product code for B&L L-BETA, MODEL WL-B1 is EKR.

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Related Devices (Code: EKR)

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.

K042828OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700Young O/S, LLCK031664ELEMENTS OBTURATION UNITSybron Endo/AnalyticK860569ENDODONTIC ROOT CANAL PLUGGERDentsply Intl.K831748ENDODONTIC ROOT CANAL PLUGGER FINGER-Union BranchK791019MCSPADDEN CONDENSORTechdent, 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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