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FDA 510(k)

ENIGMA HI-BASE DENTURE BASE MATERIAL

K-Number: K993717 · 1999-12-22

ApplicantDavis Schottlander & Davis, Ltd.
Decision Date1999-12-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENIGMA HI-BASE DENTURE BASE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Davis Schottlander & Davis, Ltd.. It received FDA 510(k) clearance on 1999-12-22 under 510(k) number K993717. 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 ENIGMA HI-BASE DENTURE BASE MATERIAL?

ENIGMA HI-BASE DENTURE BASE MATERIAL is a medical device that received FDA 510(k) clearance on 1999-12-22. The listed applicant is Davis Schottlander & Davis, Ltd.. The 510(k) number is K993717.

When did ENIGMA HI-BASE DENTURE BASE MATERIAL receive FDA 510(k) clearance?

ENIGMA HI-BASE DENTURE BASE MATERIAL received FDA 510(k) clearance on 1999-12-22, under 510(k) number K993717.

Who is the listed applicant for ENIGMA HI-BASE DENTURE BASE MATERIAL?

The FDA 510(k) record lists Davis Schottlander & Davis, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENIGMA HI-BASE DENTURE BASE MATERIAL?

The FDA product code for ENIGMA HI-BASE DENTURE BASE MATERIAL is EBI.

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Other records listing Davis Schottlander & Davis, Ltd. 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.

K024252MATCH MASTER LOW FUSION PORCELAINK024250MATCH PRESS PRESSABLE CERAMICK001463SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156K984134NATURA DENTURE TEETHK984128ENIGMA DENTURE TEETHK960770MATCHMAKER/PROPAQUE PORCELAIN

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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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