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FDA 510(k)

PROCEM

K-Number: K984248 · 1999-01-08

ApplicantEspe Dental AG
Decision Date1999-01-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROCEM is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental AG. It received FDA 510(k) clearance on 1999-01-08 under 510(k) number K984248. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCEM?

PROCEM is a medical device that received FDA 510(k) clearance on 1999-01-08. The listed applicant is Espe Dental AG. The 510(k) number is K984248.

When did PROCEM receive FDA 510(k) clearance?

PROCEM received FDA 510(k) clearance on 1999-01-08, under 510(k) number K984248.

Who is the listed applicant for PROCEM?

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

What is the FDA product code for PROCEM?

The FDA product code for PROCEM is EMA.

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Other records listing Espe Dental AG 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.

K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMK011154ELIPAR FREELIGHTK002793KETAC CEM UK002364PROTEMP HK001494MODIFICATION TO PROMPT L-POPK000595DIMENSION PENTA L

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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