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FDA 510(k)

KALGINATE IMPRESSION MATERIAL

K-Number: K970594 · 1997-03-31

ApplicantTeledyne Water Pik
Decision Date1997-03-31
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KALGINATE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Teledyne Water Pik. It received FDA 510(k) clearance on 1997-03-31 under 510(k) number K970594. 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 KALGINATE IMPRESSION MATERIAL?

KALGINATE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Teledyne Water Pik. The 510(k) number is K970594.

When did KALGINATE IMPRESSION MATERIAL receive FDA 510(k) clearance?

KALGINATE IMPRESSION MATERIAL received FDA 510(k) clearance on 1997-03-31, under 510(k) number K970594.

Who is the listed applicant for KALGINATE IMPRESSION MATERIAL?

The FDA 510(k) record lists Teledyne Water Pik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALGINATE IMPRESSION MATERIAL?

The FDA product code for KALGINATE IMPRESSION MATERIAL is ELW.

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Other records listing Teledyne Water Pik 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.

K952422ELASTIC IMPRESSION CREAMK944162DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEMK940288WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENTK931380WATER PIK PLUS PLAQUE CONTROL SYSTEMK905188PERIO PIKK900547WATER PIK(R) W/ADD'L CLAIMS

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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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