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FDA 510(k)

IVORY PREMIUM RUBBER DAM

K-Number: K863816 · 1986-10-27

ApplicantColumbus Dental Mfg. Co.
Decision Date1986-10-27
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IVORY PREMIUM RUBBER DAM 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 1986-10-27 under 510(k) number K863816. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVORY PREMIUM RUBBER DAM?

IVORY PREMIUM RUBBER DAM is a medical device that received FDA 510(k) clearance on 1986-10-27. The listed applicant is Columbus Dental Mfg. Co.. The 510(k) number is K863816.

When did IVORY PREMIUM RUBBER DAM receive FDA 510(k) clearance?

IVORY PREMIUM RUBBER DAM received FDA 510(k) clearance on 1986-10-27, under 510(k) number K863816.

Who is the listed applicant for IVORY PREMIUM RUBBER DAM?

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 IVORY PREMIUM RUBBER DAM?

The FDA product code for IVORY PREMIUM RUBBER DAM is EIE.

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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

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Related Devices (Code: EIE)

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.

K182118armor LCMavrik Dental Systems, Ltd.K151945Triumph Resin DamDenali CorporationK050318BARI-KAD PACKING DEVICEBioenvelop Agro, Inc.K043301GC TION GINGIVAL PROTECTORGC America, Inc.K040797BRITESMILE MASKING CREAMBritesmile, Inc.K022522PULPDENT PUTTY DAMPulpdent Corporation

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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