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FDA 510(k)

POLYVINYL SILICONE IMPRESSION MATERIAL

K-Number: K810825 · 1981-04-14

ApplicantDental-Material Gesellschaft
Decision Date1981-04-14
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYVINYL SILICONE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dental-Material Gesellschaft. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810825. 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 POLYVINYL SILICONE IMPRESSION MATERIAL?

POLYVINYL SILICONE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is Dental-Material Gesellschaft. The 510(k) number is K810825.

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

POLYVINYL SILICONE IMPRESSION MATERIAL received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810825.

Who is the listed applicant for POLYVINYL SILICONE IMPRESSION MATERIAL?

The FDA 510(k) record lists Dental-Material Gesellschaft as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYVINYL SILICONE IMPRESSION MATERIAL?

The FDA product code for POLYVINYL SILICONE IMPRESSION MATERIAL 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 Dental-Material Gesellschaft 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.

K810813DMG-POLISHABLE COMPOSITE

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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