FDA 510(k)

TEM-STIK

K-Number: K821824 · 1982-07-06

Decision Date1982-07-06

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TEM-STIK is the device name listed in this FDA 510(k) record. The listed applicant is Coralite Dental Products, Inc.. It received FDA 510(k) clearance on 1982-07-06 under 510(k) number K821824. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEM-STIK?

TEM-STIK is a medical device that received FDA 510(k) clearance on 1982-07-06. The listed applicant is Coralite Dental Products, Inc.. The 510(k) number is K821824.

When did TEM-STIK receive FDA 510(k) clearance?

TEM-STIK received FDA 510(k) clearance on 1982-07-06, under 510(k) number K821824.

Who is the listed applicant for TEM-STIK?

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

What is the FDA product code for TEM-STIK?

The FDA product code for TEM-STIK is EMA.

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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.