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FDA 510(k)

NU-CAP CALCIUM HYDROX. PULP CAPPING

K-Number: K831575 · 1983-06-30

ApplicantCoe Laboratories, Inc.
Decision Date1983-06-30
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NU-CAP CALCIUM HYDROX. PULP CAPPING is the device name listed in this FDA 510(k) record. The listed applicant is Coe Laboratories, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831575. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NU-CAP CALCIUM HYDROX. PULP CAPPING?

NU-CAP CALCIUM HYDROX. PULP CAPPING is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K831575.

When did NU-CAP CALCIUM HYDROX. PULP CAPPING receive FDA 510(k) clearance?

NU-CAP CALCIUM HYDROX. PULP CAPPING received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831575.

Who is the listed applicant for NU-CAP CALCIUM HYDROX. PULP CAPPING?

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

What is the FDA product code for NU-CAP CALCIUM HYDROX. PULP CAPPING?

The FDA product code for NU-CAP CALCIUM HYDROX. PULP CAPPING is EJK.

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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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