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FDA 510(k)

GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO

K-Number: K932243 · 1994-04-28

ApplicantPrecious Chemicals U.S.A., Inc.
Decision Date1994-04-28
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO is the device name listed in this FDA 510(k) record. The listed applicant is Precious Chemicals U.S.A., Inc.. It received FDA 510(k) clearance on 1994-04-28 under 510(k) number K932243. 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 GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO?

GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO is a medical device that received FDA 510(k) clearance on 1994-04-28. The listed applicant is Precious Chemicals U.S.A., Inc.. The 510(k) number is K932243.

When did GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO receive FDA 510(k) clearance?

GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO received FDA 510(k) clearance on 1994-04-28, under 510(k) number K932243.

Who is the listed applicant for GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO?

The FDA 510(k) record lists Precious Chemicals U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO?

The FDA product code for GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO is EJT.

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Other records listing Precious Chemicals U.S.A., 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.

K023831UCP DENTAL MATERIALK023790UCC DENTAL MATERIAL

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

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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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