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FDA 510(k)

DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES

K-Number: K855111 · 1986-03-06

ApplicantPacific Union Dental, Inc.
Decision Date1986-03-06
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Union Dental, Inc.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K855111. 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 DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES?

DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Pacific Union Dental, Inc.. The 510(k) number is K855111.

When did DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES receive FDA 510(k) clearance?

DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES received FDA 510(k) clearance on 1986-03-06, under 510(k) number K855111.

Who is the listed applicant for DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES?

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

What is the FDA product code for DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES?

The FDA product code for DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES is ELW.

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Other records listing Pacific Union Dental, 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.

K863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARK860817ROOT CANAL ORGANIZERK855112DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYSK855113FLOSS HOLDER (PLASTIC)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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