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FDA 510(k)

BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.

K-Number: K844446 · 1985-10-29

ApplicantPulpdent Corp. of America
Decision Date1985-10-29
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp. of America. It received FDA 510(k) clearance on 1985-10-29 under 510(k) number K844446. 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 BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.?

BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. is a medical device that received FDA 510(k) clearance on 1985-10-29. The listed applicant is Pulpdent Corp. of America. The 510(k) number is K844446.

When did BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. receive FDA 510(k) clearance?

BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. received FDA 510(k) clearance on 1985-10-29, under 510(k) number K844446.

Who is the listed applicant for BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.?

The FDA 510(k) record lists Pulpdent Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.?

The FDA product code for BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. is ELW.

Related Clinical Trials

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.

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Other records listing Pulpdent Corp. of America 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.

K882576ACID ETCH GELK863834EVIDENT MARK 2 APEX LOCATORK854977FIBER MESHK853447POLYCARB WATER SETK810545PCA PERIOCARE PERIODONTAL DRESSING

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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