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FDA 510(k)

PM2002 PROLINE

K-Number: K923534 · 1994-01-31

ApplicantPlanmeca USA, Inc.
Decision Date1994-01-31
Product CodeKLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PM2002 PROLINE 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 1994-01-31 under 510(k) number K923534. 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 is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Planmeca USA, Inc.. The 510(k) number is K923534.

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

PM2002 PROLINE received FDA 510(k) clearance on 1994-01-31, under 510(k) number K923534.

Who is the listed applicant for PM2002 PROLINE?

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?

The FDA product code for PM2002 PROLINE 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 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 SOVEREIGNK923533ADMARKK923461PM2002 PROLINE, PM2002 PROLINE ECK923462DELIGHTK904953PLANMED 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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