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FDA 510(k)

CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL

K-Number: K933199 · 1994-01-06

ApplicantConfi-Dental Products Co.
Decision Date1994-01-06
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 1994-01-06 under 510(k) number K933199. 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 CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL?

CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K933199.

When did CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL receive FDA 510(k) clearance?

CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL received FDA 510(k) clearance on 1994-01-06, under 510(k) number K933199.

Who is the listed applicant for CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL?

The FDA product code for CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL is EMA.

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Other records listing Confi-Dental Products Co. as applicant

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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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