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FDA 510(k)

ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/

K-Number: K896785 · 1990-04-19

ApplicantCraft Dental Laboratory, Inc.
Decision Date1990-04-19
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ is the device name listed in this FDA 510(k) record. The listed applicant is Craft Dental Laboratory, Inc.. It received FDA 510(k) clearance on 1990-04-19 under 510(k) number K896785. 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 ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/?

ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is Craft Dental Laboratory, Inc.. The 510(k) number is K896785.

When did ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ receive FDA 510(k) clearance?

ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ received FDA 510(k) clearance on 1990-04-19, under 510(k) number K896785.

Who is the listed applicant for ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/?

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

What is the FDA product code for ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/?

The FDA product code for ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ is ELW.

Related Clinical Trials

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Other records listing Craft Dental Laboratory, Inc. 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.

K896786ZONAREX FINAL IMPRESSION COMPOUND

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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