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FDA 510(k)

PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER

K-Number: K874458 · 1988-03-18

ApplicantLustgarten Multi-Tech International, Inc.
Decision Date1988-03-18
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Lustgarten Multi-Tech International, Inc.. It received FDA 510(k) clearance on 1988-03-18 under 510(k) number K874458. 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 PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER?

PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER is a medical device that received FDA 510(k) clearance on 1988-03-18. The listed applicant is Lustgarten Multi-Tech International, Inc.. The 510(k) number is K874458.

When did PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER receive FDA 510(k) clearance?

PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER received FDA 510(k) clearance on 1988-03-18, under 510(k) number K874458.

Who is the listed applicant for PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER?

The FDA 510(k) record lists Lustgarten Multi-Tech International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER?

The FDA product code for PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER is EMA.

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Other records listing Lustgarten Multi-Tech International, 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.

K895085WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHTK8938443D DENTAL DIAMOND ROTARY INSTRUMENTS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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