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FDA 510(k)

PULPDENT RESILUTE

K-Number: K955017 · 1995-12-01

ApplicantPulpdent Corp.
Decision Date1995-12-01
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT RESILUTE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1995-12-01 under 510(k) number K955017. 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 PULPDENT RESILUTE?

PULPDENT RESILUTE is a medical device that received FDA 510(k) clearance on 1995-12-01. The listed applicant is Pulpdent Corp.. The 510(k) number is K955017.

When did PULPDENT RESILUTE receive FDA 510(k) clearance?

PULPDENT RESILUTE received FDA 510(k) clearance on 1995-12-01, under 510(k) number K955017.

Who is the listed applicant for PULPDENT RESILUTE?

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

What is the FDA product code for PULPDENT RESILUTE?

The FDA product code for PULPDENT RESILUTE is EMA.

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Other records listing Pulpdent Corp. 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.

K014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION III

View all 78 devices →

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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