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FDA 510(k)

AMALGAM CARRIER

K-Number: K945220 · 1995-01-11

ApplicantBuffalo Dental Mfg. Co., Inc.
Decision Date1995-01-11
Product CodeEKI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALGAM CARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Buffalo Dental Mfg. Co., Inc.. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K945220. The device is classified under product code EKI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMALGAM CARRIER?

AMALGAM CARRIER is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Buffalo Dental Mfg. Co., Inc.. The 510(k) number is K945220.

When did AMALGAM CARRIER receive FDA 510(k) clearance?

AMALGAM CARRIER received FDA 510(k) clearance on 1995-01-11, under 510(k) number K945220.

Who is the listed applicant for AMALGAM CARRIER?

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

What is the FDA product code for AMALGAM CARRIER?

The FDA product code for AMALGAM CARRIER is EKI.

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Other records listing Buffalo Dental Mfg. Co., 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.

K955573OPTIBLAST INTRAORAL SANDBLASTERK941954NON-FOGGING DENTAL MIRRORK841491CONVENTIONAL PLASTIC DENTAL TRAYSK841490POLYSULFIDE CUSTOM TRAY MATERIALK841323FUZZY TRAYK820489ULTRAFINE TRAY ADHESIVE

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Related Devices (Code: EKI)

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.

K781034PREMIER INLAY PLACERPremier Dental Products Co.

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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