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FDA 510(k)

POLO DENTAL UNIT

K-Number: K854647 · 1986-06-05

ApplicantAlpine Dental Equipment Co.
Decision Date1986-06-05
Product CodeKLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLO DENTAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Alpine Dental Equipment Co.. It received FDA 510(k) clearance on 1986-06-05 under 510(k) number K854647. The device is classified under product code KLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLO DENTAL UNIT?

POLO DENTAL UNIT is a medical device that received FDA 510(k) clearance on 1986-06-05. The listed applicant is Alpine Dental Equipment Co.. The 510(k) number is K854647.

When did POLO DENTAL UNIT receive FDA 510(k) clearance?

POLO DENTAL UNIT received FDA 510(k) clearance on 1986-06-05, under 510(k) number K854647.

Who is the listed applicant for POLO DENTAL UNIT?

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

What is the FDA product code for POLO DENTAL UNIT?

The FDA product code for POLO DENTAL UNIT is KLC.

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.

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Other records listing Alpine Dental Equipment 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.

K880474AREA (DENTAL CHAIR)K880475SKEMA (DENTAL UNIT)K854642SOLAR CARTK854643SOLARK854645GOLD AIR, GOLD LIGHTK854641SOLAR F

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Related Devices (Code: KLC)

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.

K233921Luvis Chair (LC700C)Dentis Co., Ltd.K151987DCI Edge Dental Chair with Operative UnitDciK071353FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48CShanghai Foshion Medical Instruments Co., Ltd.K971063OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIRKing Dental Corp.K963209PROSTYLE COMPACTPlanmeca OyK942870ULTIMA 2 DENTAL CHAIRDentech Corp.

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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