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FDA 510(k)

INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH

K-Number: K854765 · 1986-06-13

ApplicantC&C Systems, Inc.
Decision Date1986-06-13
Product CodeEHP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH is the device name listed in this FDA 510(k) record. The listed applicant is C&C Systems, Inc.. It received FDA 510(k) clearance on 1986-06-13 under 510(k) number K854765. 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 INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH?

INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH is a medical device that received FDA 510(k) clearance on 1986-06-13. The listed applicant is C&C Systems, Inc.. The 510(k) number is K854765.

When did INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH receive FDA 510(k) clearance?

INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH received FDA 510(k) clearance on 1986-06-13, under 510(k) number K854765.

Who is the listed applicant for INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH?

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

What is the FDA product code for INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH?

The FDA product code for INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH is EHP.

Related Clinical Trials

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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. StefanoK954971ACETAL DENTAL/PREFORMED CLASPB & H Technical Services , Ltd.K800574VACUDENT LUMIX 65Vacudent 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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