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FDA 510(k)

POLYCARB WATER SET

K-Number: K853447 · 1985-10-16

ApplicantPulpdent Corp. of America
Decision Date1985-10-16
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYCARB WATER SET 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 1985-10-16 under 510(k) number K853447. 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 POLYCARB WATER SET?

POLYCARB WATER SET is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Pulpdent Corp. of America. The 510(k) number is K853447.

When did POLYCARB WATER SET receive FDA 510(k) clearance?

POLYCARB WATER SET received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853447.

Who is the listed applicant for POLYCARB WATER SET?

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 POLYCARB WATER SET?

The FDA product code for POLYCARB WATER SET is EMA.

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 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.K810545PCA PERIOCARE PERIODONTAL DRESSING

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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