Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aidite PMMA

K-Number: K190217 · 2020-12-17

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2020-12-17
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Aidite PMMA is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K190217. 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 Aidite PMMA?

Aidite PMMA is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K190217.

When did Aidite PMMA receive FDA 510(k) clearance?

Aidite PMMA received FDA 510(k) clearance on 2020-12-17, under 510(k) number K190217.

Who is the listed applicant for Aidite PMMA?

The FDA 510(k) record lists Aidite (Qinhuangdao) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aidite PMMA?

The FDA product code for Aidite PMMA is EBG.

Other records listing Aidite (Qinhuangdao) Technology Co., Ltd. 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.

K253036Light-curing Coloring Materials (ALCM)K251415Additively Manufactured Aligner ResinK250534Biomic Color OpaqueK250497Additive Manufacturing (Light Curing) Crown Bridge ResinK250811Dental Zirconia CeramicK250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )

View all 16 devices →

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.

↑