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FDA 510(k)

R2 Studio Q/RCT820

K-Number: K222219 · 2022-12-06

ApplicantMegagen Implant Co., Ltd.
Decision Date2022-12-06
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

R2 Studio Q/RCT820 is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2022-12-06 under 510(k) number K222219. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R2 Studio Q/RCT820?

R2 Studio Q/RCT820 is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K222219.

When did R2 Studio Q/RCT820 receive FDA 510(k) clearance?

R2 Studio Q/RCT820 received FDA 510(k) clearance on 2022-12-06, under 510(k) number K222219.

Who is the listed applicant for R2 Studio Q/RCT820?

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

What is the FDA product code for R2 Studio Q/RCT820?

The FDA product code for R2 Studio Q/RCT820 is OAS.

Other records listing Megagen Implant 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.

K251232MegaGen Zygoma Dental Implant SystemK242030MegaGen Dental Implant AbutmentK241972BLUEDIAMOND IMPLANTK234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentK240754N2K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

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Related Devices (Code: OAS)

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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH 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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