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FDA 510(k)

ACETAL DENTAL/PREFORMED CLASP

K-Number: K954971 · 1995-12-11

ApplicantB & H Technical Services , Ltd.
Decision Date1995-12-11
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 B & H Technical Services , Ltd.. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K954971. 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 1995-12-11. The listed applicant is B & H Technical Services , Ltd.. The 510(k) number is K954971.

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

ACETAL DENTAL/PREFORMED CLASP received FDA 510(k) clearance on 1995-12-11, under 510(k) number K954971.

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

The FDA 510(k) record lists B & H Technical Services , Ltd. 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.

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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.K974622DENTAL DMicro Dental LaboratoriesK955946ACETAL DENTAL/PREFORMED CLASPPressing DI Monticelli Rag. StefanoK854765INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETHC&C Systems, Inc.K800574VACUDENT LUMIX 65Vacudent Sales Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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