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FDA 510(k)

PEKALUX(TM)

K-Number: K872243 · 1987-07-07

ApplicantColumbus Dental Mfg. Co.
Decision Date1987-07-07
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PEKALUX(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Columbus Dental Mfg. Co.. It received FDA 510(k) clearance on 1987-07-07 under 510(k) number K872243. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEKALUX(TM)?

PEKALUX(TM) is a medical device that received FDA 510(k) clearance on 1987-07-07. The listed applicant is Columbus Dental Mfg. Co.. The 510(k) number is K872243.

When did PEKALUX(TM) receive FDA 510(k) clearance?

PEKALUX(TM) received FDA 510(k) clearance on 1987-07-07, under 510(k) number K872243.

Who is the listed applicant for PEKALUX(TM)?

The FDA 510(k) record lists Columbus Dental Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEKALUX(TM)?

The FDA product code for PEKALUX(TM) is EBF.

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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Other records listing Columbus Dental Mfg. Co. 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.

K880754DRI-CLAVE LIQUID KLEENZALLK880607UTILITY WAX STRIPS, SPEARMINTK880606UTILITY WAX STRIPS, CINNAMONK872272PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYSK871164GLUMA(TM) BONDING SYSTEMK871165LUMIFOR(TM) COMPOSITE

View all 11 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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