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FDA 510(k)

SKEMA (DENTAL UNIT)

K-Number: K880475 · 1988-09-23

ApplicantAlpine Dental Equipment Co.
Decision Date1988-09-23
Product CodeKLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SKEMA (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 1988-09-23 under 510(k) number K880475. 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 SKEMA (DENTAL UNIT)?

SKEMA (DENTAL UNIT) is a medical device that received FDA 510(k) clearance on 1988-09-23. The listed applicant is Alpine Dental Equipment Co.. The 510(k) number is K880475.

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

SKEMA (DENTAL UNIT) received FDA 510(k) clearance on 1988-09-23, under 510(k) number K880475.

Who is the listed applicant for SKEMA (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 SKEMA (DENTAL UNIT)?

The FDA product code for SKEMA (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)K854647POLO DENTAL UNITK854642SOLAR 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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