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FDA 510(k)

PALCERAM 82SF

K-Number: K972956 · 1997-09-05

ApplicantAurex Precious Metal Industries (Pty)Ltd
Decision Date1997-09-05
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALCERAM 82SF is the device name listed in this FDA 510(k) record. The listed applicant is Aurex Precious Metal Industries (Pty)Ltd. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K972956. 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 PALCERAM 82SF?

PALCERAM 82SF is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Aurex Precious Metal Industries (Pty)Ltd. The 510(k) number is K972956.

When did PALCERAM 82SF receive FDA 510(k) clearance?

PALCERAM 82SF received FDA 510(k) clearance on 1997-09-05, under 510(k) number K972956.

Who is the listed applicant for PALCERAM 82SF?

The FDA 510(k) record lists Aurex Precious Metal Industries (Pty)Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALCERAM 82SF?

The FDA product code for PALCERAM 82SF is EJT.

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Other records listing Aurex Precious Metal Industries (Pty)Ltd 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.

K972946AURELUX 77K972945AURENORM 68K972949AURELUX BIO Y85PFK972943AURECAST 92K972954PALAUREX 78K972953PALAUREX 76KF

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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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