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FDA 510(k)

ENDODONTIC ELECTRONIC SPREADER HEATER

K-Number: K853183 · 1985-10-16

ApplicantSturgeon Engineering Co.
Decision Date1985-10-16
Product CodeEKK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDODONTIC ELECTRONIC SPREADER HEATER is the device name listed in this FDA 510(k) record. The listed applicant is Sturgeon Engineering Co.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853183. The device is classified under product code EKK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDODONTIC ELECTRONIC SPREADER HEATER?

ENDODONTIC ELECTRONIC SPREADER HEATER is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Sturgeon Engineering Co.. The 510(k) number is K853183.

When did ENDODONTIC ELECTRONIC SPREADER HEATER receive FDA 510(k) clearance?

ENDODONTIC ELECTRONIC SPREADER HEATER received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853183.

Who is the listed applicant for ENDODONTIC ELECTRONIC SPREADER HEATER?

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

What is the FDA product code for ENDODONTIC ELECTRONIC SPREADER HEATER?

The FDA product code for ENDODONTIC ELECTRONIC SPREADER HEATER is EKK.

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Other records listing Sturgeon Engineering 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.

K852942WORLD PORTABLE CAUTERY

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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