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FDA 510(k)

MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT

K-Number: K052622 · 2005-12-09

ApplicantMacan Engineering Co.
Decision Date2005-12-09
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Macan Engineering Co.. It received FDA 510(k) clearance on 2005-12-09 under 510(k) number K052622. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT?

MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Macan Engineering Co.. The 510(k) number is K052622.

When did MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT receive FDA 510(k) clearance?

MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT received FDA 510(k) clearance on 2005-12-09, under 510(k) number K052622.

Who is the listed applicant for MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT?

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

What is the FDA product code for MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT?

The FDA product code for MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT is EKZ.

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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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Other records listing Macan 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.

K050735MC6A

Related Devices (Code: EKZ)

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.

K213477Root ZX3J. Morita USA, Inc.K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent, Inc.K063468THE FUGO BLADE FOR DENTISTRYMedisurg , Ltd.K050735MC6AMacan Engineering Co.K023672X O ODONTOSURGE 4Xo Care A/SK020080BONART ART-E1 ELECTROSURGERY UNITDiagnostic Data, Inc.

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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