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FDA 510(k)

VITRON H

K-Number: K991220 · 1999-05-20

ApplicantEspe Dental AG
Decision Date1999-05-20
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITRON H 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 1999-05-20 under 510(k) number K991220. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITRON H?

VITRON H is a medical device that received FDA 510(k) clearance on 1999-05-20. The listed applicant is Espe Dental AG. The 510(k) number is K991220.

When did VITRON H receive FDA 510(k) clearance?

VITRON H received FDA 510(k) clearance on 1999-05-20, under 510(k) number K991220.

Who is the listed applicant for VITRON H?

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 VITRON H?

The FDA product code for VITRON H is EBI.

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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: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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