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FDA 510(k)

DIMENSION BITE

K-Number: K991008 · 1999-06-18

ApplicantEspe Dental AG
Decision Date1999-06-18
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIMENSION BITE is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental AG. It received FDA 510(k) clearance on 1999-06-18 under 510(k) number K991008. 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 DIMENSION BITE?

DIMENSION BITE is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Espe Dental AG. The 510(k) number is K991008.

When did DIMENSION BITE receive FDA 510(k) clearance?

DIMENSION BITE received FDA 510(k) clearance on 1999-06-18, under 510(k) number K991008.

Who is the listed applicant for DIMENSION BITE?

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

What is the FDA product code for DIMENSION BITE?

The FDA product code for DIMENSION BITE is ELW.

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Other records listing Espe Dental AG 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.

K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMK011154ELIPAR FREELIGHTK002793KETAC CEM UK002364PROTEMP HK001494MODIFICATION TO PROMPT L-POPK000595DIMENSION PENTA L

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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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