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FDA 510(k)

SPACELINE DENTAL CHAIR-UNIT

K-Number: K801685 · 1980-08-04

ApplicantPacific Dental Corp.
Decision Date1980-08-04
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPACELINE DENTAL CHAIR-UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Dental Corp.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801685. 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 SPACELINE DENTAL CHAIR-UNIT?

SPACELINE DENTAL CHAIR-UNIT is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Pacific Dental Corp.. The 510(k) number is K801685.

When did SPACELINE DENTAL CHAIR-UNIT receive FDA 510(k) clearance?

SPACELINE DENTAL CHAIR-UNIT received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801685.

Who is the listed applicant for SPACELINE DENTAL CHAIR-UNIT?

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

What is the FDA product code for SPACELINE DENTAL CHAIR-UNIT?

The FDA product code for SPACELINE DENTAL CHAIR-UNIT is EIA.

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Other records listing Pacific Dental Corp. as applicant

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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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