FDA 510(k)

DEN TEMP

K-Number: K821581 · 1982-06-14

Decision Date1982-06-14

Product CodeEMB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DEN TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Majestic Drug Co., Inc.. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K821581. 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 DEN TEMP?

DEN TEMP is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Majestic Drug Co., Inc.. The 510(k) number is K821581.

When did DEN TEMP receive FDA 510(k) clearance?

DEN TEMP received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821581.

Who is the listed applicant for DEN TEMP?

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

What is the FDA product code for DEN TEMP?

The FDA product code for DEN TEMP is EMB.

Other records listing Majestic Drug Co., 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.

K101771RELINE-IT MODEL RELINE-IT K964773DENTEMP ONE STEP

Related Devices (Code: EMB)

K161630Provicol QM PlusVoco GmbH K120695DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KITDentist IN A Box Pty., Ltd.K110759TEMPOCEMDmg USA, Inc.K073539PROVISA CEMCavex Holland BV K020158NON-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.