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FDA 510(k)

PCA PERIOCARE PERIODONTAL DRESSING

K-Number: K810545 · 1981-03-24

ApplicantPulpdent Corp. of America
Decision Date1981-03-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PCA PERIOCARE PERIODONTAL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp. of America. It received FDA 510(k) clearance on 1981-03-24 under 510(k) number K810545. 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 PCA PERIOCARE PERIODONTAL DRESSING?

PCA PERIOCARE PERIODONTAL DRESSING is a medical device that received FDA 510(k) clearance on 1981-03-24. The listed applicant is Pulpdent Corp. of America. The 510(k) number is K810545.

When did PCA PERIOCARE PERIODONTAL DRESSING receive FDA 510(k) clearance?

PCA PERIOCARE PERIODONTAL DRESSING received FDA 510(k) clearance on 1981-03-24, under 510(k) number K810545.

Who is the listed applicant for PCA PERIOCARE PERIODONTAL DRESSING?

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

What is the FDA product code for PCA PERIOCARE PERIODONTAL DRESSING?

The FDA product code for PCA PERIOCARE PERIODONTAL DRESSING is EMA.

Related Clinical Trials

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Other records listing Pulpdent Corp. of America 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.

K882576ACID ETCH GELK863834EVIDENT MARK 2 APEX LOCATORK854977FIBER MESHK844446BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.K853447POLYCARB WATER SET

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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