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FDA 510(k)

SHUR GEL

K-Number: K830083 · 1983-02-07

ApplicantColumbus Dental Mfg. Co.
Decision Date1983-02-07
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SHUR GEL 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 1983-02-07 under 510(k) number K830083. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHUR GEL?

SHUR GEL is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Columbus Dental Mfg. Co.. The 510(k) number is K830083.

When did SHUR GEL receive FDA 510(k) clearance?

SHUR GEL received FDA 510(k) clearance on 1983-02-07, under 510(k) number K830083.

Who is the listed applicant for SHUR GEL?

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 SHUR GEL?

The FDA product code for SHUR GEL is ELW.

Other records listing Columbus Dental Mfg. Co. as applicant

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Related Devices (Code: ELW)

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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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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