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FDA 510(k)

DENTAL D

K-Number: K974622 · 1998-02-10

ApplicantMicro Dental Laboratories
Decision Date1998-02-10
Product CodeEHP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL D is the device name listed in this FDA 510(k) record. The listed applicant is Micro Dental Laboratories. It received FDA 510(k) clearance on 1998-02-10 under 510(k) number K974622. The device is classified under product code EHP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL D?

DENTAL D is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Micro Dental Laboratories. The 510(k) number is K974622.

When did DENTAL D receive FDA 510(k) clearance?

DENTAL D received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974622.

Who is the listed applicant for DENTAL D?

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

What is the FDA product code for DENTAL D?

The FDA product code for DENTAL D is EHP.

Related Clinical Trials

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Related PubMed Literature

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.

PMID: 41318466Development trend of Artificial Intelligence (AI) in dentistry: exploring FDA-cleared dental devices.BMC oral health ()

Other records listing Micro Dental Laboratories 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.

K984467FUSICRYLK980613PROGOLD ELECTROCOPING SYSTEM

Related Devices (Code: EHP)

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.

K022032ACETALInovativ, LLCK983558ACETAL DENTAL/PREFORMED CLASPDentamax, Inc.K954971ACETAL DENTAL/PREFORMED CLASPB & H Technical Services , Ltd.K955946ACETAL DENTAL/PREFORMED CLASPPressing DI Monticelli Rag. StefanoK854765INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETHC&C Systems, Inc.K800575VACUDENT LUMIX 70Vacudent Sales Corp.

Official Source

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