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FDA 510(k)

SPOTAR

K-Number: K810839 · 1981-04-29

ApplicantMoyco Industries, Inc.
Decision Date1981-04-29
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPOTAR is the device name listed in this FDA 510(k) record. The listed applicant is Moyco Industries, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810839. 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 SPOTAR?

SPOTAR is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Moyco Industries, Inc.. The 510(k) number is K810839.

When did SPOTAR receive FDA 510(k) clearance?

SPOTAR received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810839.

Who is the listed applicant for SPOTAR?

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

What is the FDA product code for SPOTAR?

The FDA product code for SPOTAR is ELW.

Related Clinical Trials

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Other records listing Moyco Industries, 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.

K932511SILICONE MIRRORK833558X-RAY SHIELDK821444COLORED WEDGE USED TO SEPARATE TEETHK821629FIXIDENTK810912ALLOY COMPOSITE POLISH

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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