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FDA 510(k)

ACETAL DENTAL/PREFORMED CLASP

K-Number: K983558 · 1999-01-07

ApplicantDentamax, Inc.
Decision Date1999-01-07
Product CodeEHP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACETAL DENTAL/PREFORMED CLASP is the device name listed in this FDA 510(k) record. The listed applicant is Dentamax, Inc.. It received FDA 510(k) clearance on 1999-01-07 under 510(k) number K983558. 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 ACETAL DENTAL/PREFORMED CLASP?

ACETAL DENTAL/PREFORMED CLASP is a medical device that received FDA 510(k) clearance on 1999-01-07. The listed applicant is Dentamax, Inc.. The 510(k) number is K983558.

When did ACETAL DENTAL/PREFORMED CLASP receive FDA 510(k) clearance?

ACETAL DENTAL/PREFORMED CLASP received FDA 510(k) clearance on 1999-01-07, under 510(k) number K983558.

Who is the listed applicant for ACETAL DENTAL/PREFORMED CLASP?

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

What is the FDA product code for ACETAL DENTAL/PREFORMED CLASP?

The FDA product code for ACETAL DENTAL/PREFORMED CLASP is EHP.

Related Clinical Trials

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.

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Other records listing Dentamax, 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.

K990448THE.R.MO.FREE

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, LLCK974622DENTAL DMicro Dental LaboratoriesK954971ACETAL 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

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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