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FDA 510(k)

POLYSULFIDE CUSTOM TRAY MATERIAL

K-Number: K841490 · 1984-06-27

ApplicantBuffalo Dental Mfg. Co., Inc.
Decision Date1984-06-27
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYSULFIDE CUSTOM TRAY MATERIAL 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 1984-06-27 under 510(k) number K841490. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSULFIDE CUSTOM TRAY MATERIAL?

POLYSULFIDE CUSTOM TRAY MATERIAL is a medical device that received FDA 510(k) clearance on 1984-06-27. The listed applicant is Buffalo Dental Mfg. Co., Inc.. The 510(k) number is K841490.

When did POLYSULFIDE CUSTOM TRAY MATERIAL receive FDA 510(k) clearance?

POLYSULFIDE CUSTOM TRAY MATERIAL received FDA 510(k) clearance on 1984-06-27, under 510(k) number K841490.

Who is the listed applicant for POLYSULFIDE CUSTOM TRAY MATERIAL?

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 POLYSULFIDE CUSTOM TRAY MATERIAL?

The FDA product code for POLYSULFIDE CUSTOM TRAY MATERIAL is ELW.

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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 TRAYSK841323FUZZY TRAYK820489ULTRAFINE TRAY ADHESIVE

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Related Devices (Code: ELW)

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.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

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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