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FDA 510(k)

PM 2000 DENTAL UNIT

K-Number: K842357 · 1984-09-12

ApplicantPlanmeca USA, Inc.
Decision Date1984-09-12
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PM 2000 DENTAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca USA, Inc.. It received FDA 510(k) clearance on 1984-09-12 under 510(k) number K842357. 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 PM 2000 DENTAL UNIT?

PM 2000 DENTAL UNIT is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is Planmeca USA, Inc.. The 510(k) number is K842357.

When did PM 2000 DENTAL UNIT receive FDA 510(k) clearance?

PM 2000 DENTAL UNIT received FDA 510(k) clearance on 1984-09-12, under 510(k) number K842357.

Who is the listed applicant for PM 2000 DENTAL UNIT?

The FDA 510(k) record lists Planmeca USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PM 2000 DENTAL UNIT?

The FDA product code for PM 2000 DENTAL UNIT is EIA.

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Other records listing Planmeca USA, Inc. 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.

K111361PLANMED NUANCE EXCELK081699PLANMECA SOVEREIGNK923534PM2002 PROLINEK923533ADMARKK923462DELIGHTK923461PM2002 PROLINE, PM2002 PROLINE EC

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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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