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FDA 510(k)

SOLAR

K-Number: K854643 · 1986-03-14

ApplicantAlpine Dental Equipment Co.
Decision Date1986-03-14
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLAR 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 1986-03-14 under 510(k) number K854643. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLAR?

SOLAR is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Alpine Dental Equipment Co.. The 510(k) number is K854643.

When did SOLAR receive FDA 510(k) clearance?

SOLAR received FDA 510(k) clearance on 1986-03-14, under 510(k) number K854643.

Who is the listed applicant for SOLAR?

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 SOLAR?

The FDA product code for SOLAR is EIA.

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.

K880475SKEMA (DENTAL UNIT)K880474AREA (DENTAL CHAIR)K854647POLO DENTAL UNITK854642SOLAR CARTK854645GOLD AIR, GOLD LIGHTK854641SOLAR F

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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