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FDA 510(k)

C-5 PALLADIUM BASE DENTAL ALLOY

K-Number: K891514 · 1989-04-12

ApplicantMacdonald Metals and Ceramics
Decision Date1989-04-12
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

C-5 PALLADIUM BASE DENTAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Macdonald Metals and Ceramics. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K891514. 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 C-5 PALLADIUM BASE DENTAL ALLOY?

C-5 PALLADIUM BASE DENTAL ALLOY is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Macdonald Metals and Ceramics. The 510(k) number is K891514.

When did C-5 PALLADIUM BASE DENTAL ALLOY receive FDA 510(k) clearance?

C-5 PALLADIUM BASE DENTAL ALLOY received FDA 510(k) clearance on 1989-04-12, under 510(k) number K891514.

Who is the listed applicant for C-5 PALLADIUM BASE DENTAL ALLOY?

The FDA 510(k) record lists Macdonald Metals and Ceramics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-5 PALLADIUM BASE DENTAL ALLOY?

The FDA product code for C-5 PALLADIUM BASE DENTAL ALLOY is EJT.

Related Clinical Trials

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Other records listing Macdonald Metals and Ceramics 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.

K891530M-77 GOLD BASE DENTAL ALLOYK891516C-89 GOLD BASE DENTAL ALLOYK891525M-46 GOLD BASE DENTAL ALLOYK891532M-70 GOLD BASE DENTAL ALLOYK891517C-63 GOLD BAE DENTAL ALLOYK891534M-75 GOLD BASE DENTAL ALLOY

View all 22 devices →

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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