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FDA 510(k)

POLYCARBONATE TEMPORARY CEMENT

K-Number: K802662 · 1980-12-16

ApplicantBuffalo Dental Mfg. Co., Inc.
Decision Date1980-12-16
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYCARBONATE TEMPORARY CEMENT 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 1980-12-16 under 510(k) number K802662. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYCARBONATE TEMPORARY CEMENT?

POLYCARBONATE TEMPORARY CEMENT is a medical device that received FDA 510(k) clearance on 1980-12-16. The listed applicant is Buffalo Dental Mfg. Co., Inc.. The 510(k) number is K802662.

When did POLYCARBONATE TEMPORARY CEMENT receive FDA 510(k) clearance?

POLYCARBONATE TEMPORARY CEMENT received FDA 510(k) clearance on 1980-12-16, under 510(k) number K802662.

Who is the listed applicant for POLYCARBONATE TEMPORARY CEMENT?

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 POLYCARBONATE TEMPORARY CEMENT?

The FDA product code for POLYCARBONATE TEMPORARY CEMENT is EMA.

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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 SANDBLASTERK945220AMALGAM CARRIERK941954NON-FOGGING DENTAL MIRRORK841491CONVENTIONAL PLASTIC DENTAL TRAYSK841490POLYSULFIDE CUSTOM TRAY MATERIALK841323FUZZY TRAY

View all 11 devices →

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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