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FDA 510(k)

TOKUSO REBASE

K-Number: K896981 · 1990-05-15

ApplicantTokuyama America, Inc.
Decision Date1990-05-15
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOKUSO REBASE is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama America, Inc.. It received FDA 510(k) clearance on 1990-05-15 under 510(k) number K896981. 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 TOKUSO REBASE?

TOKUSO REBASE is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Tokuyama America, Inc.. The 510(k) number is K896981.

When did TOKUSO REBASE receive FDA 510(k) clearance?

TOKUSO REBASE received FDA 510(k) clearance on 1990-05-15, under 510(k) number K896981.

Who is the listed applicant for TOKUSO REBASE?

The FDA 510(k) record lists Tokuyama America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOKUSO REBASE?

The FDA product code for TOKUSO REBASE is EBI.

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Other records listing Tokuyama America, Inc. 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.

K022641TOKUYAMA REBASE IIK011854TOKUYAMA M-BONDK011685BISTITE II DCK010267PALFIQUE ESTELITE LV CLEARK002863PALFIQUE ESTELITE LVK993917TOKUYAMA ONE-UP-BOND F

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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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