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FDA 510(k)

POLY SULFIDE IMPRESSION PASTE W/CATALYST

K-Number: K800393 · 1980-04-10

ApplicantAmerican Dental Research
Decision Date1980-04-10
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLY SULFIDE IMPRESSION PASTE W/CATALYST is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Research. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800393. 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 POLY SULFIDE IMPRESSION PASTE W/CATALYST?

POLY SULFIDE IMPRESSION PASTE W/CATALYST is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is American Dental Research. The 510(k) number is K800393.

When did POLY SULFIDE IMPRESSION PASTE W/CATALYST receive FDA 510(k) clearance?

POLY SULFIDE IMPRESSION PASTE W/CATALYST received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800393.

Who is the listed applicant for POLY SULFIDE IMPRESSION PASTE W/CATALYST?

The FDA 510(k) record lists American Dental Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLY SULFIDE IMPRESSION PASTE W/CATALYST?

The FDA product code for POLY SULFIDE IMPRESSION PASTE W/CATALYST is ELW.

Related Clinical Trials

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.

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Other records listing American Dental Research 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.

K800389ANTERIOR & POST. RESTORATIVE PASTE SYS.K800391PAINT-ON-RESTORATIVE W/FISSURE SEALERK800390ANT. & POST. RESTORATIVE POWDER LIQ.K800392BRACKET BONDING SYSTEM METAL & 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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