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FDA 510(k)

DENTIMEDIC DENTAL EMERGENCY KIT

K-Number: K861681 · 1986-09-23

ApplicantDentimedic
Decision Date1986-09-23
Product CodeEMB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIMEDIC DENTAL EMERGENCY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentimedic. It received FDA 510(k) clearance on 1986-09-23 under 510(k) number K861681. The device is classified under product code EMB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTIMEDIC DENTAL EMERGENCY KIT?

DENTIMEDIC DENTAL EMERGENCY KIT is a medical device that received FDA 510(k) clearance on 1986-09-23. The listed applicant is Dentimedic. The 510(k) number is K861681.

When did DENTIMEDIC DENTAL EMERGENCY KIT receive FDA 510(k) clearance?

DENTIMEDIC DENTAL EMERGENCY KIT received FDA 510(k) clearance on 1986-09-23, under 510(k) number K861681.

Who is the listed applicant for DENTIMEDIC DENTAL EMERGENCY KIT?

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

What is the FDA product code for DENTIMEDIC DENTAL EMERGENCY KIT?

The FDA product code for DENTIMEDIC DENTAL EMERGENCY KIT is EMB.

Related Clinical Trials

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Related Devices (Code: EMB)

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.

K161630Provicol QM PlusVoco GmbHK120695DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITDentist IN A Box Pty., Ltd.K110759TEMPOCEMDmg USA, Inc.K073539PROVISA CEMCavex Holland BVK020158NON-EUGENOL TEMPORARY CEMENTJ. Morita USA, Inc.K941066DENTAL 911L.A.F. Industries, Inc.

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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