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FDA 510(k)

ENIGMA DENTURE TEETH

K-Number: K984128 · 1999-02-09

ApplicantDavis Schottlander & Davis, Ltd.
Decision Date1999-02-09
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENIGMA DENTURE TEETH 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 1999-02-09 under 510(k) number K984128. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENIGMA DENTURE TEETH?

ENIGMA DENTURE TEETH is a medical device that received FDA 510(k) clearance on 1999-02-09. The listed applicant is Davis Schottlander & Davis, Ltd.. The 510(k) number is K984128.

When did ENIGMA DENTURE TEETH receive FDA 510(k) clearance?

ENIGMA DENTURE TEETH received FDA 510(k) clearance on 1999-02-09, under 510(k) number K984128.

Who is the listed applicant for ENIGMA DENTURE TEETH?

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 DENTURE TEETH?

The FDA product code for ENIGMA DENTURE TEETH is ELM.

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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 0156K993717ENIGMA HI-BASE DENTURE BASE MATERIALK984134NATURA DENTURE TEETHK960770MATCHMAKER/PROPAQUE PORCELAIN

View all 7 devices →

Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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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