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FDA 510(k)

AIR BURBINE HANDPIECE-DENTAL SCALING

K-Number: K831037 · 1983-05-09

Decision Date1983-05-09
Product CodeELB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIR BURBINE HANDPIECE-DENTAL SCALING is the device name listed in this FDA 510(k) record. The listed applicant is Taco Dental, Inc.. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831037. The device is classified under product code ELB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR BURBINE HANDPIECE-DENTAL SCALING?

AIR BURBINE HANDPIECE-DENTAL SCALING is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Taco Dental, Inc.. The 510(k) number is K831037.

When did AIR BURBINE HANDPIECE-DENTAL SCALING receive FDA 510(k) clearance?

AIR BURBINE HANDPIECE-DENTAL SCALING received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831037.

Who is the listed applicant for AIR BURBINE HANDPIECE-DENTAL SCALING?

The FDA 510(k) record lists Taco Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR BURBINE HANDPIECE-DENTAL SCALING?

The FDA product code for AIR BURBINE HANDPIECE-DENTAL SCALING is ELB.

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.

Related Devices (Code: ELB)

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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