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FDA 510(k)

CARRARA PDF, CARRARA H, CARRARA R

K-Number: K980597 · 1998-03-09

ApplicantEuropean Dental Imports, Inc.
Decision Date1998-03-09
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARRARA PDF, CARRARA H, CARRARA R is the device name listed in this FDA 510(k) record. The listed applicant is European Dental Imports, Inc.. It received FDA 510(k) clearance on 1998-03-09 under 510(k) number K980597. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARRARA PDF, CARRARA H, CARRARA R?

CARRARA PDF, CARRARA H, CARRARA R is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is European Dental Imports, Inc.. The 510(k) number is K980597.

When did CARRARA PDF, CARRARA H, CARRARA R receive FDA 510(k) clearance?

CARRARA PDF, CARRARA H, CARRARA R received FDA 510(k) clearance on 1998-03-09, under 510(k) number K980597.

Who is the listed applicant for CARRARA PDF, CARRARA H, CARRARA R?

The FDA 510(k) record lists European Dental Imports, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARRARA PDF, CARRARA H, CARRARA R?

The FDA product code for CARRARA PDF, CARRARA H, CARRARA R is EJT.

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Other records listing European Dental Imports, 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.

K982129ANTAGON PORCELAINK981001ORION VESTA DENTAL ALLOYK981002ORION WX DENTAL ALLOYK981000CARRARA PORCELAIN AND CARRARA VINCENT PORCELAINK980661CERA E DENTAL ALLOYK980660BIOGOLD PLUS DENTAL ALLOY

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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