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FDA 510(k)

ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)

K-Number: K991490 · 1999-07-15

ApplicantHarry J. Bosworth Co.
Decision Date1999-07-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) is the device name listed in this FDA 510(k) record. The listed applicant is Harry J. Bosworth Co.. It received FDA 510(k) clearance on 1999-07-15 under 510(k) number K991490. 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 ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)?

ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) is a medical device that received FDA 510(k) clearance on 1999-07-15. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K991490.

When did ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) receive FDA 510(k) clearance?

ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) received FDA 510(k) clearance on 1999-07-15, under 510(k) number K991490.

Who is the listed applicant for ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)?

The FDA 510(k) record lists Harry J. Bosworth Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)?

The FDA product code for ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) is ELW.

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Other records listing Harry J. Bosworth Co. 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.

K103585BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACPK100731BOSWORTH AIR POLISHERK061611BOSWORTH DENTIN RESINK051224BOSWORTH SEALK043170BOSWORTH BONDK040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE

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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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