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FDA 510(k)

REFLECT IMPRESSION MATERIAL

K-Number: K781689 · 1978-11-15

ApplicantKerr Corporation (Danbury)
Decision Date1978-11-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REFLECT IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 1978-11-15 under 510(k) number K781689. 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 REFLECT IMPRESSION MATERIAL?

REFLECT IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K781689.

When did REFLECT IMPRESSION MATERIAL receive FDA 510(k) clearance?

REFLECT IMPRESSION MATERIAL received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781689.

Who is the listed applicant for REFLECT IMPRESSION MATERIAL?

The FDA 510(k) record lists Kerr Corporation (Danbury) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLECT IMPRESSION MATERIAL?

The FDA product code for REFLECT IMPRESSION MATERIAL is ELW.

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Other records listing Kerr Corporation (Danbury) 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.

K051545L.E. DEMETRON IIK020091OPTILUX 501K951663TYTIN RK951511TYTIN ADMIXK942480M4 CONTRA-ANGLE HANDPIECEK940513OPTIBOND

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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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