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FDA 510(k)

CUTTER FLEX-SILICONE IMPRESSION MAT.

K-Number: K760752 · 1976-10-15

ApplicantCutter Laboratories, Inc.
Decision Date1976-10-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CUTTER FLEX-SILICONE IMPRESSION MAT. is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1976-10-15 under 510(k) number K760752. 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 CUTTER FLEX-SILICONE IMPRESSION MAT.?

CUTTER FLEX-SILICONE IMPRESSION MAT. is a medical device that received FDA 510(k) clearance on 1976-10-15. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K760752.

When did CUTTER FLEX-SILICONE IMPRESSION MAT. receive FDA 510(k) clearance?

CUTTER FLEX-SILICONE IMPRESSION MAT. received FDA 510(k) clearance on 1976-10-15, under 510(k) number K760752.

Who is the listed applicant for CUTTER FLEX-SILICONE IMPRESSION MAT.?

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

What is the FDA product code for CUTTER FLEX-SILICONE IMPRESSION MAT.?

The FDA product code for CUTTER FLEX-SILICONE IMPRESSION MAT. is ELW.

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Other records listing Cutter Laboratories, Inc. as applicant

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K861315HYPERBARIC PENETRATION EXTENSION SETK854106BAYSILEXK842324PERFOURMK834106INTRAVENOUS INFUSION CONTROLLERK832237ORTHOPEDIC CASTING TAPE MAXCASTK823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SET

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Related Devices (Code: ELW)

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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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