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FDA 510(k)

CROWN DELTA SILICONE IMPRESSION MATERIAL

K-Number: K801380 · 1980-07-08

ApplicantCrown Delta Corp.
Decision Date1980-07-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CROWN DELTA SILICONE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Crown Delta Corp.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801380. 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 CROWN DELTA SILICONE IMPRESSION MATERIAL?

CROWN DELTA SILICONE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Crown Delta Corp.. The 510(k) number is K801380.

When did CROWN DELTA SILICONE IMPRESSION MATERIAL receive FDA 510(k) clearance?

CROWN DELTA SILICONE IMPRESSION MATERIAL received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801380.

Who is the listed applicant for CROWN DELTA SILICONE IMPRESSION MATERIAL?

The FDA 510(k) record lists Crown Delta Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROWN DELTA SILICONE IMPRESSION MATERIAL?

The FDA product code for CROWN DELTA SILICONE IMPRESSION MATERIAL is ELW.

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Other records listing Crown Delta Corp. 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.

K122974TRYOUT-VPS HOLDING PASTEK041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALK955288HEARING AID IMPRESSION MATERIALK940132PODIATRIC MATERIALK930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMK926150VINYL ADDITION SILICONE SYSTEM

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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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