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FDA 510(k)

ORTHO-BITE WAX WAFER

K-Number: K863758 · 1986-10-07

ApplicantColumbus Dental Mfg. Co.
Decision Date1986-10-07
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO-BITE WAX WAFER 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 1986-10-07 under 510(k) number K863758. 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 ORTHO-BITE WAX WAFER?

ORTHO-BITE WAX WAFER is a medical device that received FDA 510(k) clearance on 1986-10-07. The listed applicant is Columbus Dental Mfg. Co.. The 510(k) number is K863758.

When did ORTHO-BITE WAX WAFER receive FDA 510(k) clearance?

ORTHO-BITE WAX WAFER received FDA 510(k) clearance on 1986-10-07, under 510(k) number K863758.

Who is the listed applicant for ORTHO-BITE WAX WAFER?

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 ORTHO-BITE WAX WAFER?

The FDA product code for ORTHO-BITE WAX WAFER is EGD.

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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, CINNAMONK872243PEKALUX(TM)K872272PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYSK871164GLUMA(TM) BONDING SYSTEM

View all 11 devices →

Related Devices (Code: EGD)

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.

K020009BRACE EZEUdent, Inc.K945535GLENROE ORTHO-SILGlenroe TechnologiesK924024ORTHO 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.

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