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FDA 510(k)

TRYOUT-VPS HOLDING PASTE

K-Number: K122974 · 2013-05-17

ApplicantCrown Delta Corp.
Decision Date2013-05-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRYOUT-VPS HOLDING PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Crown Delta Corp.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K122974. 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 TRYOUT-VPS HOLDING PASTE?

TRYOUT-VPS HOLDING PASTE is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Crown Delta Corp.. The 510(k) number is K122974.

When did TRYOUT-VPS HOLDING PASTE receive FDA 510(k) clearance?

TRYOUT-VPS HOLDING PASTE received FDA 510(k) clearance on 2013-05-17, under 510(k) number K122974.

Who is the listed applicant for TRYOUT-VPS HOLDING PASTE?

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

What is the FDA product code for TRYOUT-VPS HOLDING PASTE?

The FDA product code for TRYOUT-VPS HOLDING PASTE is EMA.

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Other records listing Crown Delta 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.

K041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALK955288HEARING AID IMPRESSION MATERIALK940132PODIATRIC MATERIALK930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMK926150VINYL ADDITION SILICONE SYSTEMK901991SILICONE ELASTOMER PUTTY

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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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