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FDA 510(k)

DiaTemp

K-Number: K192158 · 2020-02-13

ApplicantDiaDent Group International
Decision Date2020-02-13
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DiaTemp is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192158. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DiaTemp?

DiaTemp is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is DiaDent Group International. The 510(k) number is K192158.

When did DiaTemp receive FDA 510(k) clearance?

DiaTemp received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192158.

Who is the listed applicant for DiaTemp?

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

What is the FDA product code for DiaTemp?

The FDA product code for DiaTemp is EBG.

Other records listing DiaDent Group International 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.

K261166DIA-CEMK261093DIAFILK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)K254112Dia-X Sil BiteK231552Dia-CemK220804Dia-X Bond Universal

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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