FDA 510(k)

UTILITY WAX STRIPS, SPEARMINT

K-Number: K880607 · 1988-03-31

Decision Date1988-03-31

Product CodeEGD

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UTILITY WAX STRIPS, SPEARMINT 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 1988-03-31 under 510(k) number K880607. The device is classified under product code EGD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTILITY WAX STRIPS, SPEARMINT?

UTILITY WAX STRIPS, SPEARMINT is a medical device that received FDA 510(k) clearance on 1988-03-31. The listed applicant is Columbus Dental Mfg. Co.. The 510(k) number is K880607.

When did UTILITY WAX STRIPS, SPEARMINT receive FDA 510(k) clearance?

UTILITY WAX STRIPS, SPEARMINT received FDA 510(k) clearance on 1988-03-31, under 510(k) number K880607.

Who is the listed applicant for UTILITY WAX STRIPS, SPEARMINT?

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 UTILITY WAX STRIPS, SPEARMINT?

The FDA product code for UTILITY WAX STRIPS, SPEARMINT is EGD.

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Other records listing Columbus Dental Mfg. Co. as applicant

K880754DRI-CLAVE LIQUID KLEENZALL K880606UTILITY WAX STRIPS, CINNAMON K872243PEKALUX(TM)K871164GLUMA(TM) BONDING SYSTEM K872272PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS K871165LUMIFOR(TM) COMPOSITE

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Related Devices (Code: EGD)

K020009BRACE EZEUdent, Inc.K945535GLENROE ORTHO-SILGlenroe Technologies K924024ORTHO WAXHeraeus Kulzer, Inc.K923586BURNOUT MATERIALDentsply Intl.K914892SALIVA-STIMOrion Diagnostica, Inc.K922380BITE RIM WAXDentsply Intl.

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.