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FDA 510(k)

HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES

K-Number: K905155 · 1991-02-13

Decision Date1991-02-13
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Star Dental Mfg. Co.. It received FDA 510(k) clearance on 1991-02-13 under 510(k) number K905155. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES?

HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES is a medical device that received FDA 510(k) clearance on 1991-02-13. The listed applicant is Star Dental Mfg. Co.. The 510(k) number is K905155.

When did HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES receive FDA 510(k) clearance?

HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES received FDA 510(k) clearance on 1991-02-13, under 510(k) number K905155.

Who is the listed applicant for HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES?

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

What is the FDA product code for HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES?

The FDA product code for HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES is EFB.

Related Clinical Trials

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.

Other records listing Star 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.

Related Devices (Code: EFB)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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