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FDA 510(k)

PM2002 PROLINE, PM2002 PROLINE EC

K-Number: K923461 · 1992-12-21

ApplicantPlanmeca USA, Inc.
Decision Date1992-12-21
Product CodeKLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PM2002 PROLINE, PM2002 PROLINE EC 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 1992-12-21 under 510(k) number K923461. 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 PM2002 PROLINE, PM2002 PROLINE EC?

PM2002 PROLINE, PM2002 PROLINE EC is a medical device that received FDA 510(k) clearance on 1992-12-21. The listed applicant is Planmeca USA, Inc.. The 510(k) number is K923461.

When did PM2002 PROLINE, PM2002 PROLINE EC receive FDA 510(k) clearance?

PM2002 PROLINE, PM2002 PROLINE EC received FDA 510(k) clearance on 1992-12-21, under 510(k) number K923461.

Who is the listed applicant for PM2002 PROLINE, PM2002 PROLINE EC?

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 PM2002 PROLINE, PM2002 PROLINE EC?

The FDA product code for PM2002 PROLINE, PM2002 PROLINE EC is KLC.

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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 PROLINEK923533ADMARKK923462DELIGHTK904953PLANMED SOPHIE

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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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