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FDA 510(k)

FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL

K-Number: K932459 · 1993-08-09

Applicant3M Company
Decision Date1993-08-09
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 1993-08-09 under 510(k) number K932459. 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 FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL?

FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL is a medical device that received FDA 510(k) clearance on 1993-08-09. The listed applicant is 3M Company. The 510(k) number is K932459.

When did FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL receive FDA 510(k) clearance?

FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL received FDA 510(k) clearance on 1993-08-09, under 510(k) number K932459.

Who is the listed applicant for FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL?

The FDA product code for FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL is ELW.

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Other records listing 3M Company 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.

K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EK2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)

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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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